Flinn.ai

"At Flinn.ai, I lead the regulatory and quality initiatives, ensuring our solutions help medical device manufacturers automate and streamline their compliance activities to improve patient health and safety"

✅ Biggest Problems I Solved: Fast-tracked various regulatory projects within the organization, including the introduction of QMS and optimizing validation activities.
✅ Quantified Impact: Implemented ISO 27001 in less than three months, optimized existing regulatory documentation and procedures in less than six months, and implemented revenue-generating modules in one month.
✅ Primary Motivation: Help manufacturers create more innovative and safer medical devices to improve healthcare.

Flinn.ai is at the cutting edge of medical technology, specializing in developing sophisticated SaaS solutions for the MedTech industry. The company is dedicated to innovation, focusing on crafting software that automates and supports regulatory compliance, ensuring that our clients' products meet the highest standards of safety and effectiveness.

As Head of Regulatory and Quality, I oversee all our quality management systems, including ISO 27001 and ISO 13485, and introduce normative structures such as IEC 62304, ISO 14971, and ISO/TR 80002-2. Beyond regulatory activities, I am building a regulatory department, supporting the development team with R&D, maintaining close contact with clients and manufacturers, and being involved in sales, marketing, and business development.

My entrepreneurial skills have been instrumental in supporting Flinn.ai's growth and innovation. By leveraging my experience as a MedTech entrepreneur and MDR expert, I bring a unique perspective to the organization, identifying new business opportunities and driving strategic initiatives. I foster a culture of continuous improvement and innovation, encouraging cross-functional collaboration and ensuring that our solutions meet the evolving needs of the market.

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

"As Managing Partner of CommuModo, I empower medtech startups with strategic investments and innovative digital services, driving technological advancements in healthcare."

✅ Biggest problems I solved: Addressed regulatory challenges and supported innovative medtech startups with investment and digital services.
✅ Quantified Impact: Supported over 70 startups and companies with their MedTech Challenges
✅ Primary Motivation: Empower medtech startups through innovation and investment, driving technological advancements in the healthcare sector.

CommuModo GmbH is a Graz-based company dedicated to investing in innovative medtech companies and developing cutting-edge digital services to support medtech startups. Our mission is to turn bold visions into digital realities, nurturing groundbreaking ideas and driving technological advancements in the healthcare sector.

As Managing Partner of CommuModo, I have been deeply involved in assisting HealthTech and MedTech startups in navigating complex regulatory environments and securing the necessary funding for their projects. Our team of experts works closely with startups to develop comprehensive strategies that accelerate growth, ensure compliance with regulatory requirements, and drive innovation.

One of the biggest challenges we address is helping startups overcome regulatory and market entry barriers. By providing strategic investments and developing innovative digital solutions, we have supported MedTech startups and companies, enabling them to bring their products to market successfully and generate significant revenues.

At CommuModo, we are committed to empowering medtech startups by offering them the tools, resources, and funding they need to succeed. Our approach involves developing comprehensive strategies that not only accelerate growth but also enhance patient outcomes and revolutionize healthcare.

Managing Partner

SIQ Ljubljana

"As an external auditor at SIQ Ljubljana, I ensure medical device manufacturers comply with regulatory standards, enhancing patient safety and maintaining high industry standards across Europe."

✅ Biggest problems I solved: Auditing and checking medical device manufacturers to guarantee regulatory and legal compliance and thus patient safety
✅ Quantified Impact: Implemented audits in over 5 countries in Europe
✅ Primary Motivation: Improve regulatory knowledge and work together with a team of seasoned experts

The Slovenian Institute of Metrology (Notified Body 1304) is a well-respected organization that provides testing, calibration, and certification services in various fields, including medical devices. One of their primary focuses is on medical device quality management systems and compliance with the Medical Device Regulation (MDR). The institute offers comprehensive support to medical device manufacturers, importers, and distributors to help them meet the requirements of the MDR.

As an external auditor, ensuring that manufacturers comply with regulatory and legal standards to guarantee patient safety. Compliance is a complex process, and companies need to navigate various regulatory requirements to bring their products to market. My expertise in auditing and checking medical device manufacturers helps them ensure their products meet regulatory standards and ensure their compliance with ISO 13485 quality management systems for medical devices.

Over the years, I have implemented audits in over 5 countries in Europe, making a quantifiable impact in the industry. My work has helped companies to identify areas where they need to improve and take corrective actions to ensure their products comply with regulatory and legal requirements. My primary motivation is to improve regulatory knowledge and work together with a team of seasoned experts to help companies bring safe and innovative medical devices to market.

External Auditor

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.

Chief Regulatory Officer - Chief Operating Officer

Metasouvenirs

"At Metasouvenirs, I applied my startup expertise to disrupt the souvenirs market with a high-tech mobile application, achieving MVP status with minimal budget and gaining valuable insights into the tourism industry."

✅ Biggest problems I solved: Disrupted the traditional souvenirs and sightseeing industry 
✅ Quantified Impact: Organized and managed the project to reach MVP status with less than €1000.
✅ Primary Motivation: Testing the transferability of my startup and innovation skills to a new market outside of MedTech, while gaining insights into the tourism and mobile application industries.

Metasouvenirs was founded with a vision to challenge the traditional ways of creating memories and souvenirs while enhancing the tourism experience. As the co-founder and Chief Operating Officer, I led the development of a high-tech mobile application that redefined the souvenir market.

One of the biggest challenges we tackled was disrupting the status quo of souvenirs and sightseeing. We identified a gap in the market where traditional souvenirs failed to capture the essence of the moment or experience. To address this, we created a startup in the high-tech mobile application ecosystem, combining analog sights and events with the digital world to create unique and lasting memories and souvenirs.

Our quantified impact was significant. I organized and managed the project, achieving MVP status with a budget of less than €1000. This milestone demonstrated our ability to innovate and bring a new concept to market efficiently.

My primary motivation for starting this business was to apply my startup and innovation skills to a new market outside of my usual MedTech field, while learning more about the tourism and mobile application industries. This venture allowed me to test the transferability of my skills and gain valuable insights into new sectors.

Chief Operating Officer

Charly.rocks

"At Charly.rocks, I applied my MedTech process optimization skills to enhance efficiency by 400%, while gaining valuable insights into marketing and media."

✅ Biggest problems I solved: Streamlined and optimized company processes
✅ Quantified Impact: Enhanced process speeds by 400%, introduced structured and scalable processes.
✅ Primary Motivation: Testing the transferability of my MedTech process optimization skills to the media industry while learning more about marketing, media, and social media.

Charly.rocks is an Austrian media company with locations in Salzburg and Ledenitzen, dedicated to helping businesses navigate the competitive and rapidly evolving media landscape. The company's goal is to assist clients in standing out in a crowded and ever-changing digital marketplace.

In my role at Charly.rocks, I took on the challenge of streamlining and optimizing the company's internal processes to achieve maximum efficiency. By introducing structured and scalable processes, I improved process speeds by 400% on average, significantly enhancing the operational performance of the company.

My primary motivation was to test the transferability of my process optimization skills from the MedTech sector to the media industry. This experience allowed me to apply my expertise in a new context while learning more about marketing, media, and social media. I provided support to the team on regulatory topics, process optimization, and future product development, ensuring that the company could maintain a high standard of operational excellence.

By focusing on these areas, I was able to bring a level of innovation and efficiency to Charly.rocks that aligns with my personal commitment to continuous improvement and operational excellence. This experience also enabled me to develop valuable skills in marketing and media, which are crucial for my ongoing commitment to improving systems and processes in any industry.

Process Specialist - Responsible for Regulatory Compliance

Tibor Zechmeister

"During my transition period after Tremitas, I focused on identifying and laying the groundwork for innovative projects in the medical device sector, leveraging my expertise and network to continue driving advancements in healthcare."

✅ Biggest problems I solved: Personal re-orientation after Tremitas and identifying potential projects
✅ Quantified Impact: Established a solid foundation for future ventures and initiated key collaborations
✅ Primary Motivation: Exploring new challenges in the medical device industry

After my time at Tremitas, I embarked on a period of personal re-orientation to identify potential new projects within the medical device sector. During this transition, I focused on exploring innovative opportunities and laying the groundwork for future ventures. My primary motivation was to find new challenges that would allow me to continue making significant contributions to the healthcare industry, particularly in improving the lives of individuals with chronic conditions.

This phase allowed me to leverage my extensive network and industry knowledge to scout and evaluate emerging technologies and unmet needs in the medical device field. I initiated collaborations with key stakeholders, including researchers, developers, and healthcare providers, to understand the evolving landscape and identify areas where impactful advancements could be made.

Through this exploratory period, I successfully built the foundation for my next venture, ensuring that my efforts remained aligned with my passion for innovation and dedication to improving healthcare outcomes. This transition not only reinvigorated my entrepreneurial spirit but also positioned me to embark on new projects that promise to bring meaningful changes to the medical device sector.

Entrepreneurial Transition

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.

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.

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

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

Hi, my name is Tibor, and for the last 15 years, I have been on a non-stop mission:

                                                 ⚕  Innovate Health, Empower Lives 🔬

My drive and passion lie in developing and innovating solutions to improve global health. This core motivation led me to a career as a MedTech entrepreneur and regulatory affairs expert, where I dedicate my expertise to making a significant impact in the healthcare industry. I believe that it is a unique time in history to globally improve healthcare. 🚀

Over the past 12 years, I have embarked on a journey of MedTech entrepreneurship, founding and participating in four startups and ventures within the sector. Two of these ventures were medical device manufacturers, directly empowering and aiding patients with cutting-edge technology. The other two focused on creating software solutions for medical device manufacturers, optimizing and automating their processes to deliver safer and more effective medical devices. 💻

In my nearly 15-year career in regulatory affairs, I have specialized in navigating the complexities of bringing medical devices to the European market. The Medical Device Regulation (MDR) and accompanying quality management system standards are my core focus areas. My knowledge is built with a blend of hands-on experience—bringing my own medical devices to market, auditing other companies as an external auditor, and providing guidance and technology to support manufacturers. I firmly believe that strict adherence to regulatory standards is crucial for making medical devices safer and more efficient.🛡️

Throughout my career, I've witnessed firsthand the transformative power of MedTech innovation.  From pioneering developments in patient care to revolutionizing backend processes for manufacturers, each project has reaffirmed my commitment to this field. I continuously seek out new challenges and opportunities to drive progress, believing that collaboration and shared knowledge are key to overcoming the hurdles in our path.🤝

I invite you to join me on this exciting journey. Let's connect and create a healthier world through digital health and MedTech. Together, we can shape the future of healthcare, ensuring that every innovation brings us one step closer to a better, healthier world for all. 🌍 

Where can you find me? 

✅ I regularly provide content here on LinkedIn about MedTech and Regulatory Affairs --> Let's connect!
✅ I am building companies --> If you see opportunities, let's collaborate!
✅ I am at multiple conferences every year --> Let's meet in person!

Regulatory Affairs Isn’t Guesswork—It’s 12 Concrete Skills You Can Practice

Miss even one and you may ship a device that stalls at the notified-body gate.

Skip the craft and you risk:

 ❌ Gaps in your Technical Documentation
 ❌ Months lost to “please clarify” letters
 ❌ Costly redesigns when risks surface too late

Below is your EU MDR cheat sheet of 12 hard skills—the toolbox every RA newcomer should build and every veteran should keep sharp. 👇

1. Draft a Crystal-Clear Intended Purpose
↳ One paragraph that anchors classification, claims, and clinical strategy.

2. Map Devices to Annex VIII Rules
↳ Class I ↔ III decisions drive every downstream obligation.

3. Build a GSPR Evidence Matrix
↳ Link each requirement to test reports, standards, and documents.

4. Architect Annex II Technical Documentation
↳ Hyperlinked PDFs, executive summaries, and version control—readable at speed.

5. Construct a Risk Management File (ISO 14971)
↳ Hazard analysis, FMEA/FMEDA, and risk–benefit traceability in one flow.

6. Write Clinical Evaluation Plans & Reports (MEDDEV 2.7/1 rev. 4)
↳ Literature strategy, weighting, and CER conclusions auditors can follow.

7. Run Usability Engineering per IEC 62366-1
↳ Use scenarios, summative testing, and residual-risk linkage.

8. Author ISO 13485 QMS Procedures
↳ Clear ownership, KPI triggers, and revision history—no shelfware SOPs.

9. Plan Post-Market Surveillance & Craft PSURs
↳ Data sources, statistical methods, and proactive trend detection.

10. Manage Vigilance & FSCA Workflows
↳ 15-day serious-incident clock, CAPA linkage, and global variants.

11. Document Software Lifecycle per IEC 62304
↳ Software Risk Classification, verification reports, and traceability logs.

12. Assess Regulatory Change Impact
↳ Scan new MDR amendments, standards updates, and guidance—but, crucially, map them to your devices and QMS.

Master These Skills and You Gain:
 
✅ Faster, cleaner CE-mark reviews
✅ Fewer design surprises late in development
✅ A reputation as the “go-to” RA problem-solver

P.S. Which hard skill are you sharpening next—or which one would you add to the list?

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

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!

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