Flinn.ai

Flinn builds software that helps manufacturers keep documentation, evidence, and decisions current without drowning in spreadsheets. As a founding member and Head of Regulatory and Quality, I design the operating rhythm that keeps our products, our own QMS, and our customers audit ready.

What I lead

• QMS and ISMS across ISO 13485 and ISO 27001, internal audits, CAPA, supplier controls, secure development lifecycle.
• Software lifecycle and risk with engineering under IEC 62304 and ISO 14971, validation and CSV that scale with speed.
• Evidence paths for PMS and PMCF, vigilance, literature and regulatory intelligence that feed living technical documentation.
• Requirements translation with customers and Notified Bodies, alignment on acceptance criteria, audit readiness, and training.
• Building the RAQA function: hiring, playbooks, templates, review gates, and clear accountability.

What changed

• ISO 27001 implemented in under three months.
• Regulatory documentation and procedures streamlined within six months.
• First revenue generating automation module shipped in one month.
• Introduced a RegOps cadence: traceability that stays current, data driven PMS, clean routes through UDI and EUDAMED, and evidence that is easy to explain.

How I work

Founder pragmatism meets auditor discipline. I like small loops, clear owners, and decisions that are easy to explain later. Safety comes before speed. Clarity beats volume. Auditability beats buzzwords.

I build like an operator who has shipped devices and sat through real audits. That means we start from intended use and evidence, not from templates. We write things so an engineer, a clinician, and a reviewer can all act on them. If a sentence can be simpler, it will be.

Focus areas

MDR, IVDR, ISO 13485, ISO 27001, IEC 62304, ISO 14971, SaMD, validation, PMS and PMCF, vigilance, UDI, EUDAMED, risk management, clinical evaluation, regulatory automation.

Founding Member & Head of Regulatory and Quality

"At Flinn.ai, I guided the software development team through regulatory standards, significantly enhancing product development efficiency and compliance, ensuring safer and more effective healthcare technology."

✅ Biggest problems I solved: Support in mastering the challenges of software development by guiding through the IEC 62304 standard and similar standards at Flinn.ai, ensuring compliance and quality.
✅ Quantified Impact: Provided detailed, hands-on feedback and review that significantly streamlined Flinn.ai’s product development processes, enhancing both efficiency and compliance.
✅ Primary Motivation: To contribute my regulatory knowledge and auditing expertise to innovative MedTech projects, helping to shape a safer and more efficient healthcare technology landscape.

Flinn.ai is at the cutting edge of medical technology, specializing in developing sophisticated software solutions for the MedTech industry. The company is dedicated to innovation, focusing on crafting software that is not only groundbreaking but also adheres to the highest standards of regulatory compliance. This commitment ensures that our products are safe, effective, and capable of making a meaningful impact in healthcare. By entering the realm of Post Market Surveillance for medical devices, they address one of the most pressing issues of manufacturers.

As a MedTech entrepreneur and an MDR expert, I am involved in guiding Flinn.ai towards achieving these extraordinary goals. One of my roles being an accredited auditor for a notified body allows me to bring a unique and invaluable perspective to the table. By closely examining Flinn.ai's products, I ensure they meet the highest quality standards, and my strategic advice helps shape the company’s certification roadmap. My focus is on establishing scalable regulatory and quality management processes from the ground up, contributing to the long-term success and innovation of Flinn.ai in the dynamic world of medical technology.

Strategic Advisor Regulatory Affairs

Commumodo

CommuModo backs and builds with MedTech founders. As Co-Founder & Managing Partner, I pair operator experience and auditor insight to help early teams turn ideas into compliant, marketable products without wasted cycles.

What CommuModo does

• Invests in and supports startups building medical devices and SaMD.
• Aligns product strategy, evidence, and quality from day one so claims, risks, and usability are clear.
• Shares patterns across the founder network to cut rework and surprises.

My activities

I lead regulatory and quality strategy across portfolio and partner companies. Typical work: define intended purpose and claims, classify under MDR/IVDR, map GSPRs into a technical documentation structure that will scale, and set up lean ISO 13485 QMS. I run risk management under ISO 14971 that engineers actually use, and SaMD lifecycle practices under IEC 62304 with usability per IEC 62366. I design clinical evaluation approaches (literature, performance, and real-world data), stand up PMS and PMCF that feed design, and prepare teams for Notified Body interactions with clean traceability, supplier control, UDI/EUDAMED, and proportionate change management. I also help founders get diligence-ready by turning regulatory plans into clear milestones.

Selected outcomes

• Supported 70+ startups and scale-ups through classification, first QMS builds, and initial submissions.
• Cut time to first acceptable technical documentation by focusing on testability and traceability.
• Ran focused workshops on MDR/IVDR, QMS, risk, PMS/PMCF, and NB expectations that improved investor and partner diligence outcomes.
• Built lightweight templates and checklists teams still use after handover.

Focus areas

Digital health and sensors, neurology and movement disorders, AI in MedTech, regulatory intelligence and PMS automation. CommuModo exists to compound hard-won lessons from building, auditing, and shipping so founders move faster without compromising safety.

Co-Founder & Managing Partner

SIQ Ljubljana

At SIQ Ljubljana, I lead audits of medical device manufacturers against ISO 13485 and assess MDR technical documentation. My perspective combines founder pragmatism and auditor discipline: clear intent, traceable evidence, proportionate expectations.

What I audit

• ISO 13485 QMS: design and development, production, purchasing and supplier control, CAPA, complaint handling, vigilance, internal audits, management review.
• MDR technical documentation: intended purpose and claims, GSPRs mapping, risk management (ISO 14971), usability (IEC 62366), software lifecycle for SaMD (IEC 62304), clinical evaluation, PMS and PMCF, UDI/EUDAMED alignment.

How I work

Safety before speed. Clarity over volume. I write findings that are specific and risk-based, so teams can close nonconformities efficiently. Traceability is the backbone: claims to evidence, hazards to controls, requirements to verification, post-market signals back to design.

What manufacturers value

• Clear sampling and rationale during audits, so expectations are transparent.
• Practical recommendations (not consulting) on applying standards without turning them into paperwork.
• Early identification of gaps that would cause review loops later (e.g., clinical benefit claims not supported by data, weak risk–benefit conclusions, or untestable requirements).
• Consistent interpretation across SaMD and hardware, including AI-enabled features.

Selected outcomes

• Conducted audits across more than seven European countries, covering class I to higher-risk devices and SaMD.
• Helped manufacturers resolve NCs faster by making root cause and evidence expectations explicit.
• Reduced repeat findings by aligning risk files, verification plans, and clinical evaluation logic.
• Improved PMS and PMCF usefulness by linking signals to risk controls and design inputs.

My goal is simple: fair, consistent audits that improve patient safety and help competent teams show what they already do well: clearly and convincingly.

External Lead Auditor ISO 13485 & MDR Technical Documentation

MedEngine

"At MedEngine, I restructured the regulatory focus and expanded our US market presence, preparing a $10 billion market within a year, reflecting my commitment to innovative healthcare solutions for Parkinson's patients."

✅ Biggest problems I solved: Restructured the regulatory and strategic focus in less than 3 months
✅ Quantified Impact: Tapped and prepared a 10bn market in less than a year.
✅ Primary Motivation: Help people with Parkinson's, develop cutting-edge solutions, expand US network

MedEngine is a Berlin-based medtech startup that specializes in Parkinson's disease. The company is focused on developing cutting-edge solutions to improve the lives of people affected by Parkinson's. MedEngine aims to bridge the gap between the research community and patients by providing innovative tools and services for Parkinson's patients, healthcare providers, and researchers. The team at MedEngine is made up of experienced professionals in the fields of medicine, biotechnology, and data science, who are passionate about making a difference in the lives of people with Parkinson's.

As the Chief Regulatory Officer at MedEngine, I have been working on regulatory and market entry strategies. In my role, I lead the regulatory activities within Europe and the United States, ensuring that our solutions comply with all requirements related to technical documentation, quality management systems, and testing. I have also been actively involved in developing MedEngine's business in the United States, building an extensive network and establishing the company as a major player in the industry.

One of the biggest problems I have solved at MedEngine was restructuring the company's regulatory and strategic focus in less than three months, while also building a US network in just six months. My primary motivation for taking on this position was to help people with Parkinson's disease and to develop cutting-edge solutions to improve patient outcomes.

Co-Founder & Chief Regulatory Officer - Chief Operating Officer

Tremitas GmbH

"As the General Manager and CEO of Tremitas, I successfully led the company into the market and sales phase, securing certifications and establishing a robust distribution network to deliver innovative solutions for Parkinson's patients globally."

✅ Biggest problems I solved: Transitioned Tremitas into the market and sales phase
✅ Quantified Impact: Fully certified devices in EU, Australia, Japan, Distribution network in 7 European countries, AUS and JPN, managing a company with over 20 stakeholders, head of rtegulatory affairs
✅ Primary Motivation: Helping people with Parkinson's and tremors and being an entrepreneur

As general manager and chief executive officer of Tremitas GmbH, my primary focus is on product development, regulatory affairs for medical devices, and overall company management. I ensure the certification and validity of current medical device and QM certificates, and head up business development and corporate management. Technical project management and R&D management are also under my purview. I ensure compliance with national and international laws and regulations, manage production and warehouse areas, oversee HR, and maintain and optimize the supply chain. I participate in marketing and sales activities, such as attending congresses, trade fairs, and bilateral discussions, as well as manage national and international IP strategies.

My biggest success has been transitioning Tremitas into the market and sales phase. This has involved obtaining full certification for our devices in the EU, Australia, and Japan, establishing a distribution network in seven European countries, as well as in AUS and JPN. In addition, I am responsible for managing a company with over 20 stakeholders, and as head of regulatory affairs, I oversee the company's adherence to regulatory requirements and ensure that our devices are safe and effective.

Founder & General Manager - Chief Executive Officer - Chief Regulatory Officer

"As the CEO and Chief Scientific Officer of Tremitas, I successfully transitioned the company into a fully operational MedTech firm, raising significant investments and securing regulatory approvals to help improve the lives of people with Parkinson's disease."

✅ Biggest problems I solved: transitioned Tremitas into a fully operating company in the medical device sector
✅ Quantified Impact: Raised 7-figure investments and grants, hired employees, finished regulatory affairs processes
✅ Primary Motivation: Helping people with Parkinson's and tremors and being an entrepreneur

As Managing Director and Chief Scientific Officer of Tremitas GmbH, I led the technical development of the Tremitas system in the medical device sector. My primary motivation was to help people with Parkinson's and tremors while also being an entrepreneur. I oversaw activities in the management of the GmbH and focused on patent law and combined IP strategies. I was responsible for the preparation, organization, and implementation of national clinical trials with over 90 patients to date.

I continuously applied national and international medical device laws and focused on the certification of medical devices of risk classes I-IIa. I acquired and contacted national and international cooperation partners for consulting, prototyping, serial transition, and clinical trials. I also managed and participated in all research and development activities within Tremitas GmbH, including the evaluation of clinical data and testing of new hardware and algorithms.

In addition, I applied and received national and international funding, and established customer contact with medical experts and self-help groups, among other customer groups. I organized, implemented, and controlled the CE certification of the Tremipen device as a medical device, analyzing, complying with, and controlling all relevant basic requirements for medical devices, including IEC 60601-1, ISO 14971, ISO 13485, ISO 10993-1, and more.

Founder & Chief Executive Officer - Chief Scientific Officer - Chief Regulatory Officer

Technische Universität Graz

"My role as a student assistant at TU Graz allowed me to enhance educational delivery and support efficient lecture implementation, reflecting my commitment to knowledge transfer and skill development."

✅ Biggest problems I solved: Lecturer needed support to efficient lecture implementation
✅ Quantified Impact: Lecture was finished on time and over 95% passed the exams
✅ Primary Motivation: Knowledge transfer, improving presentation skills

The lecture "Internet and New Media" at the Institute for Information Systems and Computer Media at the Graz University of Technology faced several challenges, including an overloaded class participation and a need for efficient implementation. As a student assistant, I provided support to the lecturer and co-designed, organized, and implemented the lecture.

The biggest problem we solved was the lecturer's workload, as they were overwhelmed with tasks and needed additional support. We developed a plan to efficiently manage the lecture and ensure it was completed on time. Our efforts paid off, as over 95% of students passed the exams.

My primary motivation for this experience was to improve knowledge transfer and presentation skills. Through the development and implementation of practical exercises and exams, we were able to provide students with a well-rounded education and ensure they had the necessary skills to succeed in their field.

As a student assistant, my role included creating and implementing practical exercises, organizing and implementing exams and tests, and ensuring the smooth operation of the lecture. By providing this support, we were able to achieve our goals of improving knowledge transfer, enhancing presentation skills, and ensuring the success of the lecture.

Our quantified impact was significant, with over 95% of students passing the exams and achieving success in their field. I am proud to have contributed to this success and to have made a positive impact on the lives and education of these students.

Student Assistent

Project Tremitas / Tremitas self-employed

"Founding Tremitas and developing the Tremipen to aid individuals with Parkinson's disease reflects my commitment to innovative healthcare solutions and entrepreneurial spirit."

✅ Biggest problems I solved: Built a MedTech Start-up out of thin air that transitioned into a company
✅ Quantified Impact: Raised 6-figure grants, progressed prototyping and built the necessary network
✅ Primary Motivation: Help people with Parkinson's and tremors and become an entrepreneur

Tremitas is a start-up company focused on developing a medical device called Tremipen to help people with Parkinson's disease. Parkinson's affects over 10 million people worldwide and current treatment options are inadequate. I was motivated to start this business because my great grandfather suffered from Parkinson's and I wanted to make a difference in the lives of others affected by the disease.

We have accomplished several milestones, including securing national funding and receiving six-figure grants to develop and refine the Tremipen. We have expanded the project with new members and partners, developed and tested the first Tremipen prototypes and associated software, and organized and implemented research and development.

In addition, we have focused on business planning, sales, and marketing. We have visited and contacted potential customers, particularly neurologists and people with Parkinson's disease, and managed the financial aspects of the project, including accounting and bookkeeping.

Our ultimate goal is to obtain certification for the Tremipen as a medical device, and we have sketched out the milestones required for certification and engaged in various preparatory activities. I am proud to lead Tremitas and to be making progress towards our mission of improving the lives of people with Parkinson's disease.

Founder & Chief Scientific Officer

WHO Collaboration Centre / Imperial College London

"My internship at the WHO Collaboration Centre and Imperial College London allowed me to contribute to international health initiatives and develop innovative medical device prototypes, aligning with my commitment to global health improvement."

✅ Biggest problems I solved: Organizing an international conference and scientific contributions
✅ Quantified Impact: Successfully organized conference and presented medical device prototypes
✅ Primary Motivation: Gain experience in the UK, work for an international organization

During my four-month internship, I was employed at the WHO headquarters in London as an assistant for research, administration, event organization, training, and data evaluation. It was an exciting opportunity to work alongside experienced professionals in the health field and learn from them.

In addition to my internship, I was also part of a research project at Imperial College London, where I was responsible for carrying out the project independently. My task was to design and implement an optical control system for gastric tubes. This project allowed me to gain valuable experience in the biomedical engineering field and develop my skills in research, development, and documentation.

One of the most significant contributions I made during my time with the WHO was my involvement in designing and implementing an international congress on non-communicable diseases. The event was a huge success, with high-level health ministry participants from over 20 countries. I was responsible for co-designing and executing the congress, which involved organizing logistics, liaising with speakers, and coordinating with stakeholders.

My work at Imperial College London and the WHO allowed me to gain practical experience and develop various skills, such as research, development, documentation, event management, and data analysis. It was an invaluable experience that prepared me for my career in the health field.

Trainee

Carinthia University of Applied Sciences / Fachhochschule Kärnten

"My role as a tutor in anatomy and physiology allowed me to significantly improve student understanding and performance, reflecting my dedication to advancing healthcare education."

✅ Biggest problems I solved: Students's issues and low grades regarding Anatomy and Physiology
✅ Quantified Impact: Vastly increased average student grades
✅ Primary Motivation: Passion for Know-How transfer

As someone who is passionate about promoting knowledge and helping others learn, I took on the position of preparing and holding tutorial lectures for anatomy and medical terminology/physiology for three semesters. During my time in this position, I quickly realized that students often struggled to fully understand the complex concepts of anatomy and physiology.

The problem of students struggling to understand anatomy and physiology is a significant one. These subjects are critical for a wide range of healthcare professions and can be challenging to master. Without the right guidance and support, many students can quickly become discouraged and disheartened.

The impact of my work was quantified through the results of the students who participated in my tutorials. In many cases, students who were struggling with the material were able to vastly improve their test results after attending my lectures. By breaking down complex concepts into manageable pieces and providing students with the tools they needed, I was able to help many individuals.

There were several reasons why I chose to take on this position and start offering tutorial lectures. First and foremost, I am passionate about promoting knowledge and helping others learn. This position provided me with an excellent opportunity to do just that. Additionally, I was excited about the opportunity to improve my presentation skills and gain more experience in the field of healthcare education.

Tutor for Anatomy and Physiology

Medical Device / Regulatory Affairs Manager | Entrepreneur | Founder | Notified Body Auditor | Certified Consultant | 2017/745 MDR | ISO 13485 | ISO 14971 | I Help MedTech Companies To Significantly Reduce Time-To-Market

I’m Tibor Zechmeister. For the last 15 years I’ve worked at the crossroads of builder, auditor, and community leader in MedTech.

I started my first medical device company in 2011 with a stubborn question: could we measure what neurologists see? We designed, certified, and launched devices to quantify neurodegenerative disease (tremor and bradykinesia). That founder decade taught me everything the hard way: clinical evaluation, risk management, usability, technical documentation, and the reality of MDR and IVDR transitions when you are racing cash burn. I wrote about those lessons along the way because sharing patterns helps the next team move faster and safer.

Wearing the Notified Body Lead Auditor hat later sharpened my view from the other side of the table. I have seen what truly raises patient safety and what only raises paperwork. I also bring people together in Austria’s regulatory community so that RA/QA experts can trade what works and learn from each other. The RAPS Austria LNG is the melting pot for these activities.

At Flinn.ai, I channel that builder and auditor perspective into AI-enabled regulatory automation. My north star has not changed since 2011: fewer loops, clearer evidence, safer products. I think of it as RegOps, turning regulatory into an operating system teams can actually run. That means technical documentation and traceability that stay current, PMS and PMCF and vigilance that are data-driven, SaMD under IEC 62304 linked to ISO 13485 and ISO 14971 risk, and clean pathways through UDI and EUDAMED. AI is not the point; auditability is.

A few principles I will not compromise on:

- Safety before speed. If a faster path risks patient safety, it is the wrong path.
- Transparency. If you cannot explain your decision trail, you don't have one.
- Ethics. We are talking about patients' lives.
- Innovation with accountability. High-tech plus human expertise, within risk-based, outcome-driven regulation.

What keeps me curious: building software that helps manufacturers prove what they already do well; making PMS and regulatory intelligence useful instead of reactive.

If you are building in MedTech, whether devices, SaMD, or IVD, and care about evidence, speed, and safety, I am always up for exchanging notes. 

I post about MDR and IVDR, SaMD and IEC 62304, ISO 13485 and ISO 14971, PMS and PMCF, EUDAMED, regulatory automation, and the EU AI Act in MedTech. 

Let's connect and have a chat.

When I step away from MedTech it’s usually for a cycling tour, strength training, and a small experiment in evidence-based self-improvement.

Christmas may have arrived a little early for the MDR and IVDR community.

Nothing has been formally approved yet, but there’s a real sense of momentum, and a beacon of hope.

This is especially encouraging for startups and for companies outside the EU looking to enter the European market. 

There is hope that finally more innovation will reach patients.

Here are a few elements:

PRRC made more workable (especially for SMEs): 

Less prescriptive qualification/experience rules and more flexibility for “external” PRRC arrangements (moving away from strict “permanently and continuously available” wording).

Annex VIII classification tweaks (targeted reclassification): 

Proposed adjustments that would down-classify certain device categories (including some software/accessories and other defined cases), reducing conformity assessment burden where risk justifies it.

Certificates & surveillance modernised: 

Removal of the hard 5-year maximum certificate validity concept, shifting to a periodic review model during validity (risk-based), aiming for fewer “administrative recertifications.”

Clinical evidence becomes more proportionate: 

Broader acceptance of equivalence and wider use of non-clinical / in silico evidence where appropriate, plus a clearer “well-established technology” concept to avoid overburdening mature technologies.

Notified Body efficiency levers: 

More flexibility for remote audits, potential less frequent surveillance (where justified), and unannounced audits becoming more for-cause rather than routine.

Change management clarity: 

Clearer categorisation of post-certification changes (what needs notification vs prior approval) and enabling predetermined change control plans to reduce rework and delays.

Vigilance and transparency streamlining: 

Longer reporting timelines for non-urgent serious incidents (with urgent cases still fast-tracked).

🎄

Tibor Zechmeister

Creating a better world by optimizing medical devices and regulatory compliance is what I strive for. 

As an experienced entrepreneur in the Healthcare and MedTech sectors, I am passionate about helping startups and established companies alike. With over 10 years of experience in the medical device space, I have become a specialist in regulatory affairs and compliance, with expertise in Quality Management Systems inm general, ISO 14971, and ISO 13485. 

I am well-versed in the latest European regulations, including the 2017/745 MDR, and I have a proven track record in consulting and supporting companies on regulatory affairs. My work as an external auditor for a notified body allows me to stay on the cutting edge of industry trends and provide valuable insights to clients. 

Here are some highlights of my past and current projects:

✔️ Successfully led regulatory compliance initiatives for multiple medical device startups, enabling them to enter the market with confidence.
✔️ Developed and implemented Quality Management Systems for healthcare providers, resulting in improved patient safety and regulatory compliance.
✔️ Conducted internal audits for companies to ensure compliance with ISO 13485 and other applicable regulations, helping them to prepare for external audits and improve their overall quality systems.
✔️ Facilitated successful CE marking for a range of medical devices, from software to complex surgical instruments.
✔️ Led a team in the development of a comprehensive regulatory strategy for a HealthTech company, resulting in expedited market entry and increased revenue.
✔️ Founded and Co-founded multiple start-ups and projects and thus know the challenges and pains of entrepreneurs

As an entrepreneur, I have been involved in a number of projects and start-ups throughout my career. I am constantly seeking new and innovative ways to solve problems and make a positive impact in the world. From founding my own medical device company to working with startups in the digital health and MedTech space, I have gained a wealth of experience and insights into what it takes to succeed as an entrepreneur.

My mission is to help companies bring innovative medical devices to market and improve patient outcomes. If you are looking for support with regulatory affairs, quality management, or strategy, I invite you to connect with me. Let's work together to create a better world through digital health and MedTech.

MORE ABOUT ME:

📷 https://www.instagram.com/tibor_zechmeister/
🌎 https://www.tibor-zechmeister.com/

GET IN TOUCH:

office(at)tibor-zechmeister.com

MDR IVDR Simplification

Founding Member & Head of Regulatory and Quality @ Flinn.ai | Notified Body Lead Auditor | Chair, RAPS Austria LNG | MedTech Entrepreneur | AI in MedTech • Regulatory Automation | MDR/IVDR • QMS • Risk Management

Wake-up call for biocompatibility: 10993-1 has moved ☕🐾

A new edition of ISO 10993-1 shifts the bar on biological evaluation planning, material information, and the link to risk management. Legacy “test lists” will not cut it. Reviewers will ask how your plan reflects the latest state of the art and why each test or justification is appropriate for your contact, duration, and materials.

Practical steps to stay ahead:

↳ Run a line-by-line gap assessment from your current BEP/BER to the 2025 clauses.

↳ Refresh material characterization and chemical information. Pull supplier data and plan confirmatory work (-18, -17, -23 where relevant).

↳ Rebuild your biological evaluation plan from risk: contact type, duration, patient groups, and known hazards.

↳ Justify any reliance on historical data and define triggers for retesting.

↳ Update procedures so change control, PMS/PMCF, and CAPA feed the bio profile.

↳ Track harmonization and recognition: EN listing in the OJ and the FDA Recognized Standards list. Document the exact clause mapping and effective dates.

Vigilance reporting isn’t paperwork. It’s protection.

When a medical device fails, real people pay the price.

Done right, vigilance reporting helps you:
✅ Spot safety risks before they escalate
✅ Prevent future harm
✅ Stay compliant
✅ Save lives

But what exactly triggers a vigilance report?

Here are 4 scenarios demand immediate action:

1. Serious injury
A patient is permanently harmed.

2. Death
A fatality may be caused by the device or misuse.

3. FSCA
A recall or software update is made to mitigate risk.

4. Public health threat
A widespread risk, like contamination or systemic defect

When these occur, you’re required to notify regulators.
Fast.

And initial reporting timelines vary by jurisdiction:

🇪🇺 EU:
• 2 days: Serious public health threat
• 10 days: Death or unanticipated serious deterioration
• 15 days: Other serious incidents

With the EU-wide EUDAMED module launching
as early as 2026…
 
🇬🇧 UK:
• 2 days: Serious public health threat
• 10 days: Death or unanticipated serious deterioration
• 15 days: Other serious incidents

🇺🇸 USA
• 30 calendar days: If initial report was incomplete

Staying compliant is not optional:

✅ Add reporting deadlines to your QMS
✅ Give yourself internal buffers (like 24h lead time)
✅ Train teams to identify critical incidents
✅ Use robust assessment checklists
✅ Conduct thorough root cause analyses

Vigilance reporting is invaluable.

It builds trust in your product.
Confidence in your brand.
And protects the integrity of your entire team.

P.S. Did you already have to submit a vigilance case to a competent authority?

⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡

MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

UDI: The Backbone of Medical Device Traceability Under MDR

Medical device safety doesn’t stop after a product reaches the market.

To initiate traceability, fast recalls, and supply chain transparency, the MDR mandates a Unique Device Identification (UDI) system.

A strong UDI system doesn’t just improve logistics, it improves risk management by enabling authorities, manufacturers, and healthcare professionals to quickly identify and manage medical devices.

But how does it work, and what does compliance look like?

1. What is UDI?
↳ A unique, trackable identifier for every medical device.
↳ Improves traceability, counterfeit prevention, and recalls.
↳ Makes sure devices can be correctly identified worldwide.

2. How is a UDI Structured?
↳ Basic UDI-DI: Highest level for a group of devices
↳ UDI-DI: Fixed code identifying device model/version.
↳ UDI-PI: Variable code including lot, serial, or expiry data.

3. UDI and EUDAMED
↳ All UDI data must be registered in EUDAMED.
↳ Enables authorities and users to verify device authenticity.
↳ Strengthens post-market surveillance and recall efficiency.

4. Where Must UDI Be Applied?
↳ Appears on labels, packaging, and in some cases, directly on devices.
↳ Machine-readable (barcode, QR code) and human-readable formats required.
↳ Applies to all MDR-regulated devices

5. Why UDI Matters for Patient Safety
↳ Fast and accurate recalls when needed.
↳ Reduces medical errors by ensuring correct device identification.
↳ Strengthens supply chain transparency and prevents counterfeits.

UDI isn’t just about following a rule, it’s about protecting patients and improving MedTech accountability.

P.S. What UDI level is most challenging for you?

⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡

MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

I’m Building a Medical Device: These Are the Experts I Assemble

One of the most common reasons for medical device failure?

A lack of understanding of regulatory requirements.

No matter how innovative the technology, without a clear certification pathway, the device may never reach the market.

That’s why assembling the right team isn’t a side task,
it’s the foundation of success.

You have your engineers and developers ready, now it's time for regulatory affairs.

Here are 5 experts I always include when certifying a medical device under the MDR:

1. The PRRC
↳ The Person Responsible for Regulatory Compliance is essential for MDR projects.
↳ They’re the “Swiss Army knife” of regulatory tasks and coordination.
↳ MDR requires strict qualifications and experience for this critical role.

2. The Quality Manager
↳ Proper quality management is non-negotiable in medical device development.
↳ This expert ensures ISO 13485 compliance and manages the QMS.
↳ While MDR doesn’t mandate experience, an effective QMS is essential.

3. The Risk Manager
↳ Risk management impacts nearly all regulatory activities under the MDR.
↳ This expert leads diverse risk teams and ensures robust assessments.
↳ ISO 14971 requires risk managers to have training and experience.

4. The Clinical Expert
↳ Clinical evaluation is one of the most complex aspects of MDR compliance.
↳ They bridge clinical indications and the technology being developed.
↳ 5–10 years of experience in the relevant field is typically required.

5. The Biocompatibility Expert
↳ For most physical devices, biocompatibility is a key development focus.
↳ This expert handles material analysis, toxicology, and biological evaluations.
↳ ISO 10993-1 requires highly trained professionals for these tasks.

With these experts, you can develop your device effectively and meet MDR
requirements for technical documentation.

Remember: A successful medical device project isn’t just about technology.

It’s about assembling a team with the right skills to navigate regulatory challenges.

P.S. What additional experts would you add to this team? Let’s discuss!

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I’m Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let’s connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

5 Essential Standards for Your Next MDR Project

When it comes to MDR compliance, standards aren’t just guidelines, they’re your roadmap to success. 

With thousands of options, how do you know where to focus?

Some standards apply to almost every project and create a strong compliance base. 

Here are 5 key standards I always rely on:

ISO 13485

↳ Defines a quality management system specific to medical devices.
↳ Helps ensure all processes are consistent, quality-driven, and compliant.
↳ Essential for establishing trust in product quality from design through production.

ISO 14971

↳ Provides a structured approach to managing risks in medical devices.
↳ Helps identify, assess, and control potential hazards.
↳ Critical for patient safety and a core MDR requirement.

IEC 62366-1

↳ Sets usability engineering standards to enhance product safety.
↳ Guides design to reduce user errors and promote safe use.
↳ Vital for ensuring the device is effective and intuitive for end-users.

IEC 60601-1 (for electrical devices)

↳ Outlines safety requirements for electrical medical equipment.
↳ Ensures all electrical components meet high safety and performance standards.
↳ A must for any device with electrical functionality to pass regulatory review.

IEC 62304 (for software)

↳ Establishes best practices for the entire software lifecycle.
↳ Covers development, testing, and maintenance to ensure software reliability.
↳ Essential for any device with software, as compliance here is non-negotiable.

By using these standards, you build a robust compliance framework for your project.

Skipping secondary standards may cause setbacks. But missing these essentials? 

That could put your entire project at risk.

P.S. What additional standards do you consider essential?

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

The First Impressions Set the Tone of an Audit: Make Them Count

After several onsite and virtual audits, I can tell, almost instantly, whether a manufacturer will glide or grind through the next two days.

Yes, there are initial signs and hints and yes, it is possible to prepare for them.

Below is a six-point checklist I share with anybody who wants an audit to feel like a strategy review, not a stress test.

1️⃣ Share the Quality Manual in Advance

↳ Send the current PDF at least one week before Day 1.
↳ A healthy manual shows several controlled revisions every year: evidence that procedures evolve, not collect dust.

Prep time: 30 min to export + 2 h internal spot-check for outdated links.

2️⃣ Show a Management Review That Tracks New Regulations

↳ Include a table that lists MDR amendments, ISO changes, and MDCG guidance published since the last review.
↳ Define input channels (reg-watch service, NB newsletters, industry forums) so auditors see the radar, not just the blips.
 
Prep time: ½ day to update the table; worth every minute.

3️⃣ Present a One-Page “What Changed” Briefing

↳ Headcount shifts, market feedback, design updates, cover the last 12 months.
↳ This transparency lets the audit focus on facts rather than detective work.
 
Prep time: 1–2 h with your cross-functional leads.

4️⃣ Bring Top Management to the Table

↳ CEO or site lead joins the opening, closing, and management sections.
↳ Ten minutes of visible commitment unlock faster decisions during the audit.
 
Prep time: Calendar invites, send them now, not the night before.

5️⃣ Keep a Single, Complete CAPA List

↳ One spreadsheet (or database view) that merges internal findings, last external audit actions, and significant events.
↳ No hidden tabs, no side lists, one source of truth builds instant trust.
 
Prep time: 1 h to reconcile lists, 15 min to add status notes.

6️⃣ Lay Out PMS Files: Ready to Discuss

↳ PSURs, complaint trend graphs, FSCA log, and summary conclusions within arm’s reach.
↳ When teams know their post-market story, the auditor’s tough questions sound like confirmation, not confrontation.
 
Prep time: ½ day to print or hyperlink the latest versions.

Why Invest This Effort Up Front?
 ✅ Smooth, interruption-free audit flow
 ✅ Fewer “Please provide…” scramble breaks
 ✅ A reputation with NBs that provides calmness next year

Auditors and manufacturers: what single practice gives you a confident start?

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

Liat Nadel

6 Must-Have Sections for Your Intended Purpose Document

Your Intended Purpose document impacts 90% of your MDR certification journey. 

Small changes here can have massive consequences later on.

There’s ongoing debate: Should this document be short and crisp, or highly detailed? 

I’m firmly in the "detailed" camp.

Think of it like an iceberg. 

Above the surface are obvious sections like the device’s purpose and functionality. 

But below the water lies crucial information. 

Including these additional sections now will save you headaches later.

Here are 6 sections I always recommend in every Intended Purpose document:

The Intended Purpose

↳ What diagnosis, treatment, or monitoring will the device accomplish?
↳ Tip: Be as specific as possible: vague language here could lead to incorrect classifications later.

The Intended Use

↳ How will the device be used? By whom? What are the key steps in its operation?
↳ Tip: Include environmental conditions (e.g., hospital, home use) to cover all scenarios.

Relevant Diseases and Symptoms

↳ Which diseases or symptoms (e.g., ICD-11 codes) does the device target?
↳ Tip: Using ICD-11 terminology helps create alignment with global standards and avoids ambiguity.

Intended Users

↳ Who will use the device: patients, clinical personnel, or both?
↳ Tip: Clearly define training or expertise needed by users to prevent usability issues.

Short Technical Description

↳ What technical, physical, or biological principles make the intended purpose achievable?
↳ Tip: Include a high-level summary of how the device works without diving into full technical specs.

Parts and Components of the Medical Device

↳ Is the device a single component or a system? Are accessories required?
↳ Tip: Specify if components are reusable, disposable, or must meet additional regulatory requirements.

It’s tempting to quickly draft a few lines and move on. 

But remember, this document will shape your certification process for months or years to come.

Investing time here now means fewer roadblocks later.

P.S. What other sections do you consider essential for your Intended Purpose documents?

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

Osyma Badraldeen

What does “equivalence” mean under the MDR?
 
It is a narrow pathway that lets you use another device’s clinical data when you can prove a very close match. Miss the match and you need your own study.

1. Purpose of equivalence
 → You may rely on another device’s data to support your Clinical Evaluation when you show it meets MDR criteria and your claims. (Art. 61; Annex XIV Part A)

2. The three-part test
 → You must match technical, biological, and clinical characteristics and justify any small differences with science, not opinion. Use a line-by-line table. (Annex XIV Part A §3; MDCG 2020-5)

3. Implantable and Class III rule
 → If you claim equivalence for these, you need a contract that gives full, ongoing access to the other device’s technical documentation and PMS data. Without that access, run your own clinical investigation. (Annex XIV Part A §3; Art. 61(4))

4. Class IIa and IIb flexibility
 → You may use literature, certificates and public IFUs if they allow a complete comparison across the three characteristics. Any gaps need a justified, risk-based argument. (MDCG 2020-5)

5. What to document
 → A mapped comparison table, a gap analysis, the clinical evidence you are borrowing, and a PMCF plan that covers residual uncertainty. Link each item to the relevant GSPRs. (Annex XIV Part A; Annex XIV Part B)

6. Common pitfalls
 → Different intended purpose or population, new tissue-contact materials or durations, algorithm changes that influence diagnosis or therapy. These usually break equivalence and trigger new clinical evidence. (Annex XIV Part A §3; Annex I)

Bottom line: equivalence works only with a tight, evidence-backed match across technical, biological and clinical characteristics, and full data access for implantable or Class III devices. When in doubt, plan your own clinical investigation.

If you have any questions about regulatory, leave a comment!

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

The most dangerous myth in MedTech? 
That quality is solely QA’s job.

That belief costs companies millions.

Think about it: 

• Remediation 
• Delayed launches 
• Damaged reputations

The list goes on.

Quality isn’t a department. It’s a shared responsibility.

But here’s the nuance: 
That doesn’t mean roles don’t matter.

Here’s how to actually distribute quality ownership 
across your organization:

1. Core QA Manager Responsibilities: 

• Architect and maintain the quality system
• Help the company be ready for audits
• Oversee CAPA management and effectiveness
• Manage key documentation
• Ensure alignment with ISO 13485, MDR, and 21 
 CFR Part 820

2. Where Most Companies Go Wrong: 

• Thinking QA can catch every defect (they can't)
• Making QA write technical steps for other teams
• Keeping risk management only in quality, not with experts
• Relying on QA to clean up last-minute compliance issues
• Treating quality like the company’s rule enforcers
 
3. What Requires True Cross-Functional Partnership: 

• Working with engineering to set up clear design controls
• Solving CAPAs by fixing deeper process issues
• Monitoring product performance post-launch
• Making sure supplier quality stays strong over time
• Helping teams see documentation as a tool, not a task

You shouldn’t rely on QA Managers
to be quality superheroes. 

Instead, build a full team of quality heroes.

Bring these questions into your next team meeting:

☐ Who owns design controls, and is it clear?
☐ Is QA guiding teams, or just cleaning up messes?
☐ Have non-QA teams had any quality training lately?
☐ Are you fixing root causes or just patching problems?
☐ Do non-QA teams know how their work affects audits?

Shifting from “quality is their job” to “quality is 
our job” takes time, but the payoff is worth it:

✅ Higher team morale
✅ Better patient outcomes 
✅ Stronger relationships with regulators 

The results will speak for themselves.

P.S. How would you explain to a CEO that the QA's role is not a silo of writing documents for everyone?

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

What are Class I devices, and do they need a Notified Body?*
 
1. “Class I*” is shorthand people use for Class I devices that still require NB involvement. Under the MDR these are Class Is, Im, and Ir, and the NB review is limited to a specific aspect. (Art. 52(7))

2. Class Is → sterile
 → NB assesses the sterile-condition aspects of the conformity assessment via Annex IX or Annex XI, limited to sterilisation and related QMS elements. (Art. 52(7); Annex IX; Annex XI)

3. Class Im → measuring function
 → NB reviews the metrological aspects that affect accuracy and safety, again with a limited-scope assessment under Annex IX or Annex XI. (Art. 52(7); Annex IX; Annex XI)

4. Class Ir → reusable surgical instruments
 → NB evaluates reprocessing/cleaning/sterilisation instructions and validation for re-use; other parts remain self-declared. (Art. 52(7); Annex VIII §3)

5. Certificates and DoC
 → You still issue a Declaration of Conformity for the device. The NB issues a certificate that covers only the reviewed aspect. Both must be in place before CE marking those variants. (Art. 19; Art. 52)

6. PMS paperwork stays Class I level
 → PMS plan and PMS report are required; PSUR does not apply to Class I. Keep change control tight, updates that touch the NB-assessed aspect may require NB notification. (Art. 83–85; Art. 86)

Bottom line: “Class I*” means Class Is, Im, or Ir. Yes, a Notified Body is involved, but only for the specific aspect named in the code; the rest of the device remains self-declared under Class I rules.

If you have any questions about regulatory, leave a comment!

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

Can I add features after my initial MDR certification?
 
Yes, but treat every new feature as a formal change. Whether you need Notified-Body involvement depends on how the change touches intended purpose, risk, and conformity evidence.

1. Start with intended purpose and class
 → If a feature changes the intended purpose or pushes the device into a new risk class, you’re looking at a major change and fresh NB assessment. (Art. 2(12); Annex VIII)

2. Check your conformity route duties
 → Annex IX (QMS): you must inform the NB of substantial changes to the QMS or the device range covered. (Annex IX §2.4)
 → Type-examination: changes to the approved type require NB review and approval before placing on the market. (Art. 56(4); Annex X §6)
 → Product verification / production QA: apply the same change-notification logic per your certificate scope. (Annex XI)

3. Test “significance” against the GSPRs
 → If the feature could affect compliance with Annex I requirements (performance, safety, usability, materials, sterilisation, cybersecurity), notify the NB and submit the updated technical documentation. If not, document the rationale and evidence in your change file. (Annex I; Annex II)

4. Software features need extra checks
 → Reassess Rule 11 impact and your clinical functionality. Algorithm changes that influence diagnosis or therapy are typically significant. Align your 62304 change class with the regulatory change record, and update clinical evaluation where functionality shifts. (Annex VIII Rule 11; Annex XIV Part A)

5. Labels, IFU and claims
 → Update IFU, labels and website claims to stay aligned with the intended purpose; route edits through QMS review. (Annex I §23; Art. 7; Art. 10(9))

6. UDI impact
 → Some design or performance changes trigger a new UDI-DI, and major scope shifts can require a new Basic UDI-DI and certificate update. Record the decision and rationale in your UDI procedure. (Art. 27; MDCG 2018-1)

7. Clinical and risk files
 → Update risk management, clinical evaluation and PMCF to cover the new feature, and reflect it in PMS/PSUR. (Art. 61; Annex XIV Part B; Annex III)

Bottom line: you can add features after certification, but run them through formal change control. If they alter intended purpose, risk class, safety or performance claims, or trigger UDI changes, coordinate with your Notified Body before you ship.

If you have any questions about regulatory, leave a comment!

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

Certification keeps swinging when time and cash are gone ⏳💸

Startups often assume that great engineering speed will carry them to the finish line. Certification does not care about pitch decks or momentum. It cares about evidence, traceability, and reviewers who work to a fixed process. The result is predictable: timelines slip, budgets drain, and the real blocker turns out to be missing data and late scope changes.

Practical moves that protect the runway:

↳ Build a single plan to CE or FDA with the true critical path. Include NB queue times and test lab lead times.

↳ Expect two or three NB question rounds. Add a 20 to 30 percent schedule buffer.

↳ Freeze intended purpose and claims before verification starts.

↳ Write the evidence plan from the GSPR or 21 CFR first, then test.

↳ Reserve NB capacity early and book a pre-sub or structured dialogue.

↳ Align funding tranches to regulatory milestones with a readiness checklist.

Do I need to purchase the standards I claim compliance with?
 
Short answer: the MDR does not force you to buy standards, but you must apply them correctly and show what you applied. In practice, that means controlled access to the exact text and edition.

1. What the law asks for
 → You must demonstrate conformity with the GSPRs in your technical documentation and QMS. Harmonised standards give presumption of conformity, but they are optional. (Art. 10; Art. 8; Annex II 4; Annex I)

2. If you cite a harmonised EN, have the text and edition
 → Auditors will look for clause-level evidence and the Annex Z mapping. Without the actual document, you cannot show how you applied it. The presumption of conformity only applies to the EN edition listed in the OJEU. (Art. 8)

3. Using non-harmonised ISO/IEC editions is possible
 → You can use state of the art standards that are not harmonised, but you lose automatic presumption. Add a GSPR cross-walk and justify any differences. (Annex I; Art. 8)

4. Edition control matters
 → If you apply a newer edition than the one listed in the OJEU, note it in your matrix and justify equivalence or superiority. Presumption attaches to the listed edition only. (Art. 8)

5. Access routes that work in audits
 → Company purchase from a national standards body, an organisation-wide subscription, or a documented library access. Keep the edition and access location in your document register.

6. Common Specifications are free
 → Where CS exist, they are binding or require an equivalent level of safety and performance. Download and cite them directly. (Art. 9)

Bottom line: you are not legally required to buy every standard, but if you claim compliance you need controlled access to the exact text and edition you applied, plus a clear GSPR cross-walk.

If you have any questions about regulatory, leave a comment!

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

Is it really possible to 10X efficiency in 30 days?

Imagine, in one month: 

Your team moves from firefighting 
to driving real progress.

Regulations are easier to manage, 
and paperwork is no longer a burden.

And errors? They become a rare occurrence.

AI makes it all possible.

Here's your roadmap to QM transformation:

1. AI-Powered Document Control
 ↳ Implement automatic updates and approvals

2. Complaint Handling on Autopilot
 ↳ AI categorizes and prioritizes
 
3. Smart Risk Management
 ↳ AI spots issues before they cost you
 
4. Always Audit-Ready
 ↳ AI organizes compliance docs
 
5. Repetitive Tasks? Automated.
 ↳ AI handles data entry and filings
 
6. Real-Time Regulatory Updates
 ↳ AI monitors changes across markets
 
7. CAPA That Works for You
 ↳ Flags non-conformities instantly
 
8. Smart Quality Dashboards
 ↳ Provide predictive insights instantly

9. Post-Market Surveillance 24/7
 ↳ Keeps products compliant after launch

10. Literature Review Made Easy
 ↳ Updates you effortlessly

This isn't just change. It's a whole new way of working.

The future of quality management is here.

What would it mean for your company?

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MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference.

I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed.

Let's connect and collaborate to streamline regulatory work for everyone!

#automation
#regulatoryaffairs
#medicaldevices

Transitional time feels long until it isn’t ⏱️⚡

MDR extensions only help if you meet the conditions. Many teams assume they are safe, then discover late that they never lodged an NB application, lacked an MDR-compliant QMS, or made “significant changes.” Transitional periods are not a pause. They are a contract: keep PMS and vigilance to MDR level, hold certification under the Directives, and keep moving toward full MDR conformity.

How to stay out of trouble:

↳ Confirm eligibility under the latest Article 120 rules and write down which condition you rely on.

↳ Lock NB capacity now: submit the application, get a written agreement, and track their timelines.

↳ Upgrade the QMS to MDR requirements and document the date it became effective.

↳ Run a “significant change” check for every update to design, intended purpose, and manufacturing.

↳ Keep PMS and PMCF active and trending.

↳ Build a dated plan to reach full MDR certification and review it every month.

Big claims need real proof: show what the app actually does 🔬📱

Bold AI features are great, but diagnostic claims live or die on clinical evidence. Reviewers look for a clear intended purpose, defined target conditions, and data that proves performance in the right patients and settings. “Diagnoses 100 diseases” invites scrutiny you do not need. Tighten the claim, then build evidence that matches it.

Practical steps that work:

↳ Freeze the intended purpose and priority indications.

↳ Map each claim to endpoints and acceptance criteria.

↳ Build an evidence stack: literature for scientific validity, analytical tests, then clinical performance with a prespecified protocol and comparator.

↳ Use governed datasets: provenance, labeling process, splits, external validation, prevalence, sensitivity, specificity, ROC, PPV/NPV.

↳ Check bias and generalizability across age, sex, site, and device models.

↳ Document model change control, real-world monitoring, and PMS links.

↳ Make labeling and IFU mirror the evidence, word for word.

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