Easy Medical Device

After Brexit, EMD UK is now the UK Responsible Person for Medical Device manufacturers that want to continue business in England.

CEO and Co-Founder

Company helping Medical Device Manufacturers to learn about Medical Device Regulation and standards.
- Offering consulting services on the area of Quality and Regulatory affairs. 
- EU Authorized Representative
- UK Responsible Person
- Blog: https://easymedicaldevice.com/blog
- Youtube Channel - http://www.youtube.com/c/EasyMedicalDevice
- Podcast - Medical Device made Easy - https://podcast.easymedicaldevice.com

We provide support for people and companies who want to learn how to place a compliant Medical Device on the Market. Don't hesitate to contact us if you need some more information on the website or its content.

Founder & CEO

S-Cube Technologies

S-Cube Technologies is offering an eQMS that is helping companies to stay compliant.
- Support for Customer Growth
- Create an amazing experience with customers
- Improve features within the eQMS
- Update eQMS to always be aligned with legislation
- Perform Demos to customers

Co-Founder & Managing Director

Johnson & Johnson

Management of the Quality Engineering team on 2 sites with the objective of:
- Process Validation
- Problem Solving
- Improvement
- Introduction of New Products
- Introduction of New Technologies (Additive manufacturing or 3D-Printing, Injection Molding)

Quality Operation Manager

Quality person responsible of 3 production sites with orthopaedic Implants and Instruments.

- Quality System section in charge of Document Control, metrics reporting and support of Audit readiness.

- Quality Engineering section in charge of process improvement, validation and problem investigation.

- Inspection and calibration section in charge of product control and calibration of measurment equipment.

High collaboration with Sterility Assurance, Supplier Quality and CSV (Computer System Validation)

Plant Quality Senior Manager

Management representative.
Responsible for Quality Operation:
- Process Validation and engineering
- Inspection & Calibration 
- Quality System

Products: Orthopaedic implants and instruments for traumatology, spine and cranio-maxilo-facial.

Certification: ISO 13485, CE mark, FDA, ANVISA, JPAL

Plant Quality Manager

- Leader for the EMEA Quality and Regulatory Compliance 
- Management Representative and leader during Third Party audit
- Leading the group for Complaint management in collaboration with EMEA Technical Service
- Certification for ISO 13485 - 21 CFR 820, MDD 93/42/EC for Medical Devices
- Part of EUCOMED, SNV organizations
- Reporting to US headquarter

Quality and Regulatory Compliance Manager

Bausch + Lomb

Management of a portfolio of pharmaceutical and medical devices products.
Coordination of the products registration all over the world.
RA leader for new product development, CTA submissions
Management of Borderline products (Class III) - Medical devices containing an ingredient that could be considered a drug.

Dealing with health authorities (Bfarm, AFSSAPS, MHRA, TUV, MDC...) for the submissions, variation, renewal, deficiency letters...

Regulatory affairs manager, Global

Scient'x

Management of 2 departements with 6 direct reports and 12 Quality inspectors
- Quality department divided on Quality Management System (QMS), Design control, Suppliers management and compliance management.
- Regulatory Affairs with Technical file management (development and lifecycle).
- Management of products registered in the US under 510k.

Certification ISO 13485 - 9001, FDA et RDC,  Brazil (ANVISA), Taïwan

Head of Quality and Regulatory Affairs

Aesculap (group BBraun Medical)

- Quality system and Regulatory management for medical devices from class I to class III (Knee implants) - ISO 13485 + Directive 93/42/EC (2007/47/EC)
- Implementation of a new CAPA system to make it more practical
- Internal, supplier and Third party audit management.
- Process Validation IQ OQ PQ for manufacturing machines. Six sigma, lean manufacturing.
- Project management for the investment of an Ultrasound washing machine for implants

Quality and Regulatory Affairs Manager

Problem solving (Brainstorming, ischikawa, pareto, FMECA...)
ISO 13485 and FDA for the process validation (IQ, OQ, PQ).
Internal and external auditor.
Product risk management
Project leader for machine investment
Management of non-conformity

Process Validation Engineer

Micro Mega

I am actually the help of the Quality Manager. I organize all about Directive 93/42/ce with the ISO 13485 and also the Canadien laws.
I Manage all the system of the entreprise. Training for the project Manager and Improvement of the performances.

Biomedical Engineer

micro mega

CE marking of medical devices instruments.
MDD 93/42/CE
ISO 14971
ISO 13485

My wish is to support the needs of pharmaceutical and medical devices companies to reach their objectives and to help patients to obtain the product they need. 

I've acquired during my career sufficient knowledge to drive projects related to quality and regulatory affairs and had experienced many successes but also some difficulties which helped me to learn more.

To start that journey I created EasyMedicalDevice.com which is here to bring some awareness on all the new regulations transitions that are ongoing.

As you can see by the name of the site, the objective is to make the Medical Device Regulations and Standards easy to understand. 

Read my blog posts and look at my Youtube channel and subscribe to my podcast (Medical Device made Easy) so you can learn how to place a compliant medical device on the market.

My Motto is: "WOULD I GIVE THIS PRODUCT TO A MEMBER OF MY FAMILY?" so don't forget that health is one of the most important pieces of your life. Don't destroy it.

About me:
For my background, I am specialized in Quality and Regulatory Affairs for Medical Devices and also have some experience in Medicinal Products. This helped me to acquire knowledge of combination products and borderline products.

Below are some of the standards and regulations I practiced:
For devices - Medical Device Directive MDR 2017/745, IVDR 2017/746, MDD 93/42/EC, 98/79/EC for IVD, FDA 21CFR 820, ANVISA, JPAL and 510K registration, ISO 13485:2016, ISO 14971.

Related to drug - I follow Drug Directive 2001/83/EC.

Additionally, I drove some Process improvement (Change management, PDCA, CAPA)
Lean manufacturing (SMED (Pit stop), Value Stream Mapping, 5S, 6 sigmas)

🚨 𝐌𝐀𝐉𝐎𝐑 𝐈𝐒𝐎 10993-1 𝐔𝐏𝐃𝐀𝐓𝐄𝐒 𝐈𝐌𝐌𝐈𝐍𝐄𝐍𝐓! 🚨
The 2025 revision of ISO 10993-1 is nearing publication, introducing significant changes to the evaluation of medical devices for biological safety. Manufacturers should prepare now, as many regions, particularly Europe, are expected to consider the new standard as State-of-the-Art immediately upon release.

𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐤𝐞𝐲 𝐬𝐡𝐢𝐟𝐭𝐬 𝐢𝐧 𝐛𝐢𝐨𝐜𝐨𝐦𝐩𝐚𝐭𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐞𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 𝐞𝐱𝐩𝐥𝐚𝐢𝐧𝐞𝐝 𝐟𝐨𝐫 𝐲𝐨𝐮𝐫 𝐢𝐧𝐟𝐨𝐠𝐫𝐚𝐩𝐡𝐢𝐜:

1️⃣ 𝑰𝒏𝒄𝒓𝒆𝒂𝒔𝒆𝒅 𝑭𝒐𝒄𝒖𝒔 𝒐𝒏 𝑹𝒊𝒔𝒌 𝑴𝒂𝒏𝒂𝒈𝒆𝒎𝒆𝒏𝒕 & 𝑬𝒙𝒑𝒆𝒓𝒕𝒊𝒔𝒆 🧐
The standard moves definitively away from a traditional "checkbox approach".
• ISO 14971 Integration
• Author Qualifications

2️⃣ 𝑹𝒆𝒄𝒂𝒕𝒆𝒈𝒐𝒓𝒊𝒛𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝑪𝒐𝒏𝒕𝒂𝒄𝒕 𝑫𝒖𝒓𝒂𝒕𝒊𝒐𝒏 (𝑪𝒖𝒎𝒖𝒍𝒂𝒕𝒊𝒗𝒆 𝑼𝒔𝒆)  🔄
The approach to repeat-use devices has changed significantly, impacting categorisation and required testing.
• Cumulative Contact.
• Bioaccumulation.

3️⃣ 𝑴𝒂𝒏𝒅𝒂𝒕𝒆 𝒕𝒐 𝑬𝒗𝒂𝒍𝒖𝒂𝒕𝒆 𝑭𝒐𝒓𝒆𝒔𝒆𝒆𝒂𝒃𝒍𝒆 𝑴𝒊𝒔𝒖𝒔𝒆 🤔
Manufacturers must now consider foreseeable misuse—usage that may seem reasonable in a clinical setting but was not initially intended by the manufacturer.
• This includes off-label use.
• Failure to address foreseeable misuse can lead to regulatory pushback and necessitate reassessing endpoints and potentially repeating costly testing, especially chemical characterisation (ENL).

4️⃣ 𝑺𝒉𝒊𝒇𝒕𝒊𝒏𝒈 𝑩𝒊𝒐𝒍𝒐𝒈𝒊𝒄𝒂𝒍 𝑬𝒏𝒅𝒑𝒐𝒊𝒏𝒕𝒔 🔬
The requirements for specific tests are being adjusted:
• Material Mediated Pyrogenicity (MMP) Removal.
• Increased Genotoxicity.

5️⃣ 𝑳𝒊𝒇𝒆 𝑪𝒚𝒄𝒍𝒆 & 𝑫𝒆𝒈𝒓𝒂𝒅𝒂𝒕𝒊𝒐𝒏 𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆 ♻️
The update includes new guidance on evaluating biocompatibility risks across the entire product life cycle (including prototyping) and clearer requirements for assessing device degradation risks over its useful life.

What should you do now? You can start performing a Gap Assessment on your current Biological Evaluation documentation and Quality Management System procedures. This is crucial to identify and prioritise necessary updates before submission, especially if you are pursuing European markets.

W̳a̳n̳t̳ ̳a̳ ̳d̳e̳e̳p̳e̳r̳ ̳d̳i̳v̳e̳?̳
🎧 Listen to the discussion with expert Marina Daineko: https://lnkd.in/eNh8twiN
#MedicalDevices #Biocompatibility #ISO10993 #RegulatoryAffairs #MedTech

Monir El Azzouzi

Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host

📢 𝐌𝐚𝐣𝐨𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞: 𝐓𝐡𝐞 𝐄𝐔 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐩𝐫𝐨𝐩𝐨𝐬𝐞𝐬 𝐚 𝐭𝐚𝐫𝐠𝐞𝐭𝐞𝐝 𝐫𝐞𝐯𝐢𝐬𝐢𝐨𝐧 𝐨𝐟 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 (𝐌𝐃𝐑/𝐈𝐕𝐃𝐑)!
The European Commission proposed a comprehensive simplification of the rules for medical devices and in vitro diagnostic medical devices (IVDs) on 1̳6̳ ̳D̳e̳c̳e̳m̳b̳e̳r̳ ̳2̳0̳2̳5̳. The objective is to make the rules easier, faster, and more effective, while promoting competitiveness, innovation, and maintaining a high level of patient safety. This revision addresses structural problems identified in the current framework, aiming to reduce administrative burdens and enhance predictability.

Key Simplification Measures in the Proposal:
🔹 𝑹𝒊𝒔𝒌-𝑩𝒂𝒔𝒆𝒅 𝑪𝒆𝒓𝒕𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏: The maximum period of validity for certificates (currently 5 years) is proposed to be removed. Instead of costly re-certification, notified bodies would conduct periodic reviews proportionate to the device's risk.
🔸 𝑹𝒆𝒅𝒖𝒄𝒆𝒅 𝑨𝒅𝒎𝒊𝒏𝒊𝒔𝒕𝒓𝒂𝒕𝒊𝒗𝒆 𝑩𝒖𝒓𝒅𝒆𝒏: The proposal simplifies rules for micro and small enterprises (SMEs), requiring external regulatory compliance personnel to be "available" rather than "permanently and continuously available". Additionally, reporting timelines for serious incidents not related to public health threats or death are extended from 15 to 30 days.
🔹 𝑩𝒐𝒐𝒔𝒕𝒊𝒏𝒈 𝑰𝒏𝒏𝒐𝒗𝒂𝒕𝒊𝒐𝒏: Dedicated pathways are introduced for breakthrough devices and orphan devices (intended for small patient populations). These devices would benefit from prioritized and rolling reviews during conformity assessment.
🔸 𝑺𝒕𝒓𝒆𝒂𝒎𝒍𝒊𝒏𝒆𝒅 𝑬𝒗𝒊𝒅𝒆𝒏𝒄𝒆 𝑮𝒆𝒏𝒆𝒓𝒂𝒕𝒊𝒐𝒏: Manufacturers are encouraged to expand the use of equivalence data, non-clinical data, and in silico testing to streamline the clinical evidence process. Definitions for categories like "well-established technology device" are introduced to apply more proportionate requirements.
🔹 𝑫𝒊𝒈𝒊𝒕𝒂𝒍𝒊𝒛𝒂𝒕𝒊𝒐𝒏 𝒂𝒏𝒅 𝑬𝒇𝒇𝒊𝒄𝒊𝒆𝒏𝒄𝒚: The framework promotes the digital submission of documents and information. It also establishes a central IT tool to facilitate the reporting and information exchange regarding interruptions or discontinuations in supply, strengthening the ability to manage medical device shortages.

The combined quantifiable impact of these simplification measures is estimated to yield over €3 billion in savings per year across the sector.

Learn more about the full proposal and its implications for the medical device sector: ➡️ https://lnkd.in/e-AbBysZ

#medicaldevice #eumdr #eucommission #easymedicaldevice #regulatoryaffairs

The next podcast will be about that topic with Marina Daineko, so stay tuned for valuable information on what it contains.
Check it here on Thursday: https://lnkd.in/e4tU5AC

#medicaldevices #easymedicaldevice #regulatoryaffairs #biocompatibility #ISO10993

Quality and Regulatory Affairs Leader | Medical Devices Expert | Lead Auditor | Mechanical Engineer (Product Development) | Continuous / Process Improvement Champion

🔴📢 REGULATORY UPDATE! 🔴📢
🌍✨ ISO 10993-1:2025 is officially published! ✨🌍
🎉📜 Biological Evaluation of Medical Devices – Part 1
✅ Edition 6 (2025) replaces ISO 10993-1:2018

🔍 What’s New?
✅ Risk-Based Approach aligned with ISO 14971
✅ Lifecycle Biological Safety – from design ➡️ disposal
✅ Material Characterization & Scientific Justification
✅ Updated Contact Categories & Exposure Duration Rules
✅ Greater Documentation Requirements (BEP, BER, RMF)
✅ Consideration of Reasonably Foreseeable Misuse

💡 Why It Matters?
✅ Ensures patient safety through systematic biological risk assessment
✅ Supports global regulatory compliance 🌍
✅ Promotes efficient testing strategies & reduces animal use 🐾
✅ Facilitates early detection of biological hazards

📌 Action for Manufacturers:
✅ Download the standard
✅ Conduct a gap analysis
✅ Update your biological evaluation plans

🌟 ISO 10993-1:2025 = A New Era of Biocompatibility Evaluation! 🌟
📅 Published: 18 November 2025
🔗 Learn more on ISO.org

🌐 Global Impact:
🇪🇺 European Union (EU MDR)
🇺🇸 United States (FDA)
🇨🇦 Canada (Health Canada)
🇯🇵 Japan (PMDA)
🇨🇳 China (NMPA)
🇦🇺 Australia (TGA)

🚀 Let’s embrace risk-based, scientifically justified, lifecycle-oriented biological safety!

📢 Spread the Word!
✅ Share this post with your network to keep the industry informed!

#ISO10993 #MedicalDevices #Biocompatibility #RiskManagement #ISO14971 #RegulatoryCompliance #Medtech #Regulatoryupdates #regulatoryaffairs #isostandard

🚀 𝐄𝐔𝐃𝐀𝐌𝐄𝐃 𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐔𝐬𝐞 𝐓𝐢𝐦𝐞𝐥𝐢𝐧𝐞 𝐂𝐨𝐧𝐟𝐢𝐫𝐦𝐞𝐝! 𝐌𝐚𝐫𝐤 𝐘𝐨𝐮𝐫 𝐂𝐚𝐥𝐞𝐧𝐝𝐚𝐫𝐬! 🚀
The European regulatory landscape for medical devices has solidified its timeline for mandatory use of key EUDAMED modules!

Following the adoption of Commission Decision (EU) 2025/2371 on 26 November 2025, the European Commission has formally confirmed the functionality and fulfillment of specifications for four critical electronic systems within the European Database on Medical Devices (Eudamed).

The publication of this notice in the Official Journal of the European Union occurred on 27 November 2025. This act officially triggered the start of the transition periods for related mandatory obligations under Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

Based on the official timeline provided, economic operators now have a clear deadline for mandatory data submission:

𝐊𝐞𝐲 𝐄𝐔𝐃𝐀𝐌𝐄𝐃 𝐌𝐨𝐝𝐮𝐥𝐞𝐬 & 𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐓𝐢𝐦𝐞𝐥𝐢𝐧𝐞:
The independent audit confirmed the functionality of the following four modules:
1️⃣ Actors (Registration of economic operators)
2️⃣ UDI/Devices (UDI database and device registration)
3️⃣ Notified bodies and certificates
4️⃣ Market surveillance

𝐓𝐡𝐞 𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐔𝐬𝐞 𝐬𝐭𝐚𝐫𝐭𝐬 𝐞𝐱𝐚𝐜𝐭𝐥𝐲 𝐬𝐢𝐱 𝐦𝐨𝐧𝐭𝐡𝐬 𝐚𝐟𝐭𝐞𝐫 𝐭𝐡𝐞 𝐩𝐮𝐛𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐭𝐡𝐞 𝐧𝐨𝐭𝐢𝐜𝐞:
🔸 Publication of Notice (Start of 6-month period): 27 November 2025.
🔸 Mandatory Use Starts: 28 May 2026.

𝐔𝐩𝐝𝐚𝐭𝐞 𝐨𝐧 𝐭𝐡𝐞 𝐕𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐌𝐨𝐝𝐮𝐥𝐞:
The timeline for the Vigilance module is proceeding separately, contingent on an MVP Audit.
🔹 The publication of the notice for the Vigilance module is currently projected for Q4 2026.
🔹 Mandatory use for the Vigilance module is then projected for Q2 2027 (after a six-month mandatory use period).

Economic operators are strongly advised to accelerate onboarding activities for the modules declared functional, utilizing the training material available in the Information Centre.

This clear timeline provides manufacturers, authorized representatives, and other economic operators with the certainty needed to finalize their compliance strategies. Are you ready for May 2026?

♾️ 𝓢𝓸𝓾𝓻𝓬𝓮: https://lnkd.in/ep4nc2es

#EUDAMED #MDR #IVDR #MedicalDevices #RegulatoryCompliance #EUCBIM

𝐄𝐔 𝐌𝐃𝐑/𝐈𝐕𝐃𝐑 𝐀𝐥𝐞𝐫𝐭! 🚨 𝐓𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐢𝐬 𝐦𝐨𝐯𝐢𝐧𝐠 𝐭𝐨 𝐬𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐢𝐳𝐞 𝐡𝐨𝐰 𝐍𝐨𝐭𝐢𝐟𝐢𝐞𝐝 𝐁𝐨𝐝𝐢𝐞𝐬 (𝐍𝐁𝐬) 𝐨𝐩𝐞𝐫𝐚𝐭𝐞 𝐮𝐧𝐝𝐞𝐫 𝐭𝐡𝐞 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐄𝐔 2017/745) 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐈𝐕𝐃 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐄𝐔 2017/746).

A new draft Commission Implementing Regulation aims to eliminate inconsistent and divergent interpretations of requirements related to quotations, timelines, and re-certification, which currently create unequal positions for manufacturers, particularly SMEs.

This draft is designed to establish uniform quality management and procedural requirements for NBs performing conformity assessments.

Here are the three major changes proposed to increase predictability:
💰 𝑸𝒖𝒐𝒕𝒂𝒕𝒊𝒐𝒏 𝑻𝒓𝒂𝒏𝒔𝒑𝒂𝒓𝒆𝒏𝒄𝒚 & 𝑺𝒕𝒂𝒏𝒅𝒂𝒓𝒅𝒊𝒛𝒂𝒕𝒊𝒐𝒏: NBs must issue quotations that include a clear estimate of overall costs, broken down for technical documentation assessment, QMS assessment, and surveillance activities. Manufacturers must provide detailed information, including their SME status, to receive a reliable cost estimate.

⏱️ 𝑴𝒂𝒙𝒊𝒎𝒖𝒎 𝑻𝒊𝒎𝒆𝒍𝒊𝒏𝒆𝒔 𝒇𝒐𝒓 𝑨𝒔𝒔𝒆𝒔𝒔𝒎𝒆𝒏𝒕: To combat delays, strict maximum timelines are introduced for key phases, ensuring assessments are completed in the shortest feasible timeline:
- Application Review & Contract Signature: 30 days.
- Quality Management System (QMS) Auditing: 120 days.
- Product Verification (Technical Documentation): 90 days.
- Final Certification Issuance: 15 days.

✅ 𝑷𝒓𝒆𝒅𝒊𝒄𝒕𝒂𝒃𝒍𝒆 𝑹𝒆-𝒄𝒆𝒓𝒕𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏 & 𝑻𝒓𝒂𝒏𝒔𝒑𝒂𝒓𝒆𝒏𝒄𝒚: Re-certification reviews must be standardized to avoid repeating the initial comprehensive assessment. The review period for both QMS and product documentation is limited to a maximum of 60 days. Furthermore, NBs must monitor and publish an annual report on costs and assessment duration by April 30th each year to ensure transparency.

This draft regulation is essentially a rulebook for the referees (Notified Bodies), designed to streamline the certification pipeline and ensure timely market access for safe and innovative devices.

Review the preliminary draft and have your say here: 
𝓛𝓘𝓝𝓚: https://lnkd.in/eBGDDRrA

#EUMDR #EUIVDR #MedicalDevices #NotifiedBodies #RegulatoryAffairs #HealthcareInnovation

🚀 𝗦𝘁𝗶𝗹𝗹 𝘂𝗻𝘀𝘂𝗿𝗲 𝗵𝗼𝘄 𝘁𝗼 𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝘆 𝘆𝗼𝘂𝗿 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗮𝘀 𝗮 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 (𝗦𝗮𝗠𝗗)?
Here’s a quick cheat-sheet on ➡️ IMDRF Risk 𝗖𝗮𝘁𝗲𝗴𝗼𝗿𝗶𝗲𝘀 vs. EU MDR Rule 11 𝗖𝗹𝗮𝘀𝘀𝗲𝘀—plus why getting it right the first time protects your timeline, budget and market-entry strategy.

📊 1. 𝗧𝗵𝗲 𝘁𝘄𝗼 𝘀𝗰𝗮𝗹𝗲𝘀—𝘀𝗮𝗺𝗲 𝗴𝗼𝗮𝗹, 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝗹𝗮𝗻𝗴𝘂𝗮𝗴𝗲
• 𝗜𝗠𝗗𝗥𝗙 (International Medical Device Regulators Forum) looks at:
– 𝗦𝘁𝗮𝘁𝗲 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 (Non-Serious / Serious / Critical)
– 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝗰𝗲 𝗼𝗳 𝗜𝗻𝗳𝗼 (Inform / Drive / Diagnose-Treat)
→ 𝗖𝗮𝘁𝗲𝗴𝗼𝗿𝗶𝗲𝘀 I-IV (IV = highest risk).
• 𝗘𝗨 𝗠𝗗𝗥 (Rule 11) converts that into regulatory workload:
→ 𝗖𝗹𝗮𝘀𝘀 I, IIa, IIb, III (III = highest risk).

🧩 2. 𝗠𝗮𝗽𝗽𝗶𝗻𝗴 𝗶𝘁 𝗶𝗻 𝘀𝗶𝗺𝗽𝗹𝗲 𝘁𝗲𝗿𝗺𝘀
IMDRF IV ➡️ Class III (Critical impact—possible death/irreversible deterioration)
IMDRF III ➡️ Class IIb (Serious impact—may need surgery)
IMDRF II ➡️ Class IIa (Lower but still clinically significant)
IMDRF I ➡️ Class I (Lowest risk—standard PMS & no NB for CE)

⏱️ 3. 𝗪𝗵𝘆 𝗶𝘁 𝗺𝗮𝘁𝘁𝗲𝗿𝘀—𝗯𝗲𝘆𝗼𝗻𝗱 𝗮𝗰𝗮𝗱𝗲𝗺𝗶𝗰𝘀
Mis-classification can trigger:
❌ 𝗥𝗲𝗳𝘂𝘀𝗮𝗹 𝗳𝗿𝗼𝗺 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝗶𝗲𝘀 (major non-conformity).
🔄 𝗥𝗲𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 + 𝗲𝘅𝘁𝗿𝗮 𝗱𝗼𝗰𝘀: clinical evaluation, cybersecurity tests, human-factors, AI/ML change control, PMCF.
💸 𝗖𝗼𝘀𝘁 𝗼𝘃𝗲𝗿𝗿𝘂𝗻𝘀: additional verification/validation, penetration testing, IEC 62304 upgrades.
📉 𝗚𝗼-𝘁𝗼-𝗺𝗮𝗿𝗸𝗲𝘁 𝗱𝗲𝗹𝗮𝘆𝘀: every re-review adds 3–9 months.
🛑 𝗥𝗲𝗽𝘂𝘁𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗵𝗶𝘁: regulators track history; investors do, too.

🔑 4. 𝗕𝗲𝘀𝘁 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲 𝗰𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
✔️ Use the IMDRF framework first—document rationale, reference Annex III of guidance.
✔️ Map to Rule 11 and confirm with your notified body early (pre-submission, Q-Sub, TC).
✔️ Align IEC 82304-1, 62304, 62366-1, 27001, 81001-5-1 accordingly.
✔️ Keep an 𝗶𝗻𝘁𝗲𝗿𝗱𝗶𝘀𝗰𝗶𝗽𝗹𝗶𝗻𝗮𝗿𝘆 log: clinical, QA/RA, software, cybersecurity.
✔️ Update as intended use or algorithm performance evolves—especially with AI/ML.

🎯 5. 𝗖𝗮𝗹𝗹 𝘁𝗼 𝗮𝗰𝘁𝗶𝗼𝗻
Need a 30-minute call to review your project. Don't hesitate to send me a private message at Easy Medical Device.
Let’s get your SaMD on the fast track to CE marking—without surprises. 🌍💡
#SaMD #SoftwareAsAMedicalDevice #MedicalDeviceSoftware #EU_MDR #Rule11 #IMDRF

You want a quick summary of the ISO 10993-1 2025 update. 
This will give you all the information you should consider, and with this, you'll be ready to explain to your team what to do to be compliant. 

https://lnkd.in/eKUMwvik

📢 𝐌𝐚𝐣𝐨𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐌𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞 𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐝 𝐟𝐨𝐫 𝐄𝐔 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬! 📢

The European medical device landscape has reached a significant turning point!

The European Commission has adopted Decision (EU) 2025/2371 on 26 November 2025, formally confirming the functionality and fulfillment of specifications for four critical electronic systems within the European Database on Medical Devices (Eudamed).

Eudamed, which the Commission is tasked with setting up, maintaining, and managing under Regulation (EU) 2017/745, is advancing rapidly. This confirmation followed an independent audit, which verified that these systems meet the functional specifications drawn up pursuant to Article 34(1) of Regulation (EU) 2017/745.

𝑻𝒉𝒆 𝒇𝒐𝒖𝒓 𝑬𝒖𝒅𝒂𝒎𝒆𝒅 𝒆𝒍𝒆𝒄𝒕𝒓𝒐𝒏𝒊𝒄 𝒔𝒚𝒔𝒕𝒆𝒎𝒔 𝒄𝒐𝒏𝒇𝒊𝒓𝒎𝒆𝒅 𝒂𝒔 𝒇𝒖𝒏𝒄𝒕𝒊𝒐𝒏𝒂𝒍 𝒂𝒓𝒆:
1️⃣  The electronic system for the registration of economic operators ('Actors').
2️⃣ The UDI database and the electronic system for registration of devices ('UDI and devices').
3️⃣ The electronic system on notified bodies and certificates.
4️⃣ The electronic system for market surveillance.

𝑾𝒉𝒚 𝒊𝒔 𝒕𝒉𝒊𝒔 𝒆𝒔𝒔𝒆𝒏𝒕𝒊𝒂𝒍 𝒏𝒆𝒘𝒔?
The publication of this Decision is critical because it officially triggers the start of the transition periods for the mandatory obligations and requirements that relate to these specific electronic systems under Regulations (EU) 2017/745 and (EU) 2017/746. This Decision entered into force upon its publication in the Official Journal of the European Union on 27 November 2025.

𝐀𝐜𝐭𝐢𝐨𝐧 𝐈𝐭𝐞𝐦: Economic operators must ensure immediate readiness and compliance with the use of these newly functional Eudamed systems!

Stay ahead of the curve! What steps is your organization taking to integrate these modules into your regulatory strategy?

#EUDAMED #MDR #IVDR #MedicalDevices #RegulatoryAffairs #EUCompliance

Great talk with Khanyisile Nkuku
#medicaldevice #easymedicaldevice #regulatoryaffairs

𝐇𝐀𝐑𝐌𝐎𝐍𝐈𝐙𝐀𝐓𝐈𝐎𝐍, 𝐑𝐄𝐋𝐈𝐀𝐍𝐂𝐄 & 𝐃𝐈𝐆𝐈𝐓𝐀𝐋𝐈𝐙𝐀𝐓𝐈𝐎𝐍 – 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 𝐟𝐫𝐨𝐦 𝐀𝐟𝐫𝐢𝐒𝐮𝐦𝐦𝐢𝐭 𝟐𝟎𝟐𝟓 | 𝐈𝐧𝐭𝐞𝐫𝐯𝐢𝐞𝐰 𝐰𝐢𝐭𝐡 Khanyisile Nkuku

Just wrapped up an inspiring conversation with Khanyisile Nkuku, one of the most dynamic voices in African regulatory affairs — and someone who literally made the room dance to explain harmonization! 💃🏽🎶
In this interview recorded at AfriSummit Egypt 2025, we discuss:
✨ Why harmonization across African regulatory authorities is now a strategic priority
 ✨ How reliance can be achieved not only via WHO pathways but also within Africa itself
 ✨ The crucial role of digitalization in strengthening regulatory efficiency
 ✨ How AI-driven screening could cut review timelines from days… to hours
 ✨ Why alignment of requirements between African countries is the real “magic wand”
 ✨ How digital maturity tools and AI can support scarce regulatory resources
 ✨ The one word that summarizes AfriSummit 2025: HARMONY — one rhythm, one voice, one shared mission.
This interview captures the energy, ambition, and collaborative spirit shaping the future of medical device regulation in Africa.
🎥 Watch the full interview to understand how Africa is moving from discussion… to implementation.

Monir El Azzouzi

#AfriSummit2025 #RegulatoryAffairs #MedicalDevices #AfricaRegulation #Harmonization #Reliance #DigitalHealth #AIinHealthcare #RegulatoryScience #PublicHealthInnovation #MDRAfrica #HealthcareTransformation

You have until January 28th, 2026, to provide your comments regarding the ISO 18969 for clinical evaluation. So, don't hesitate to watch this video, which summarizes the information, and then take action. 

Standard: https://lnkd.in/eCrPd-PR
Video: https://lnkd.in/ey6TPaa8
#medicaldevice #iso18969 #regulatoryaffairs #clinicalevaluation

Great interview with Rana Chalhoub from Mecomed at Afrisummit 2025 PharmaRegAfriSummit
Check how she is summarizing the event at the end. Awesome. 🤩 

#medicaldevices #easymedicaldevice #regulatoryaffairs #conferences

🎙️ Interview at AfriSummit Egypt 2025 with Rana Chalhoub from Macomed

I had the pleasure of interviewing Rana , who has attended all five editions of the AfriSummit.
 Her perspective on the evolution of the event — and the progress made in African regulatory convergence — is incredibly insightful.
During our conversation, she shared:
 - How reliance & regulatory convergence have gained momentum across Africa
 - Why reliance must now move from discussion to implementation
 - The increasing collaboration between African regulators, WHO initiatives, and regional MoUs
 - Her thoughts on the possibility of an African certification mark
 - Why international approvals can still support harmonization as a first step
 - For Macomed: the importance of continuing collaboration with regulators beyond the summit
 ✨ Her two words to summarize AfriSummit 2025: Collaboration & Mindset Shift
A great reminder that real progress in MedTech regulation happens through teamwork, trust, and continuous engagement.
🎥 Watch the interview here: https://lnkd.in/e84dcrV8
Monir El Azzouzi Rana Chalhoub
#AfriSummit #Africa #RegulatoryAffairs #Reliance #Harmonization #MedicalDevices #MedTech #Macomed #Collaboration #Innovation

𝐈𝐬 𝐲𝐨𝐮𝐫 "𝐌𝐢𝐧𝐨𝐫" 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐜𝐡𝐚𝐧𝐠𝐞 𝐚𝐜𝐭𝐮𝐚𝐥𝐥𝐲 "𝐒𝐢𝐠𝐧𝐢𝐟𝐢𝐜𝐚𝐧𝐭" 𝐭𝐨 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐬? 𝐓𝐡𝐞 𝐚𝐧𝐬𝐰𝐞𝐫 𝐜𝐨𝐮𝐥𝐝 𝐛𝐞 𝐭𝐡𝐞 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐚𝐧𝐝 𝐚 𝐜𝐨𝐬𝐭𝐥𝐲 𝐫𝐞𝐜𝐚𝐥𝐥.

We often classify medical device software updates internally as Patch, Minor, or Major. But regulatory bodies—like the FDA or those following MDCG 2020-3 guidelines—only care about two distinctions: 𝑺𝒊𝒈𝒏𝒊𝒇𝒊𝒄𝒂𝒏𝒕 𝒐𝒓 𝑵𝒐𝒏-𝑺𝒊𝒈𝒏𝒊𝒇𝒊𝒄𝒂𝒏𝒕.

This critical difference is why we need clear change management processes.

In the latest episode of the Medical Device Made Easy podcast, I sat down with Anindia Mukarja (CEO of SQ Technologies/Smart Eye) to break down the complexities of Medical Device Software Versioning and Change Control.

𝐇𝐞𝐫𝐞’𝐬 𝐰𝐡𝐚𝐭 𝐨𝐮𝐫 𝐢𝐧𝐟𝐨𝐠𝐫𝐚𝐩𝐡𝐢𝐜 𝐡𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐝𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧:
1️⃣ 𝑻𝒉𝒆 𝑭𝒐𝒖𝒓 𝑳𝒆𝒗𝒆𝒍𝒔: Internally, we define changes (often relating to resource allocation and testing) as Patch, Minor, or Major. A common versioning standard uses X.Y.Z, where Z is a Patch, Y is Minor, and X is Major.

2️⃣ 𝑴𝒂𝒋𝒐𝒓 ≠ 𝑺𝒊𝒈𝒏𝒊𝒇𝒊𝒄𝒂𝒏𝒕: A widespread confusion point is equating a Major internal change with regulatory Significance. A change can be Major (requiring extensive internal testing and resources, like replacing a discontinued LCD screen with an identical version) but still be Non-Significant from a regulatory standpoint if it doesn't impact safety, performance, or intended use.

3️⃣ 𝑴𝒊𝒏𝒐𝒓 𝑪𝒂𝒏 𝑩𝒆 𝑺𝒊𝒈𝒏𝒊𝒇𝒊𝒄𝒂𝒏𝒕: On the flip side, a small UI tweak (a Minor change) can become Significant if it accidentally alters the sequence of information in a way that risks patient safety or results in a fatal accident.

𝓒𝓱𝓪𝓷𝓰𝓮 𝓶𝓪𝓷𝓪𝓰𝓮𝓶𝓮𝓷𝓽 𝓲𝓼 𝓷𝓸𝓽 𝓳𝓾𝓼𝓽 𝓪𝓫𝓸𝓾𝓽 𝓽𝓻𝓪𝓬𝓴𝓲𝓷𝓰 𝓱𝓲𝓼𝓽𝓸𝓻𝔂; 𝓲𝓽’𝓼 𝓪𝓫𝓸𝓾𝓽 𝓲𝓶𝓹𝓪𝓬𝓽 𝓪𝓼𝓼𝓮𝓼𝓼𝓶𝓮𝓷𝓽. It ensures that even the smallest change is reviewed proactively by the Change Control Board (CCB), which should involve quality, regulatory, and patient safety stakeholders.

We discuss how tools like Smart Eye (an EQMS solution) provide a structured, scientific framework to guide these decisions and ensure proper documentation and regression testing, preventing costly errors where an already working module is accidentally broken.

👉 S̳e̳e̳ ̳t̳h̳e̳ ̳i̳n̳f̳o̳g̳r̳a̳p̳h̳i̳c̳ ̳a̳n̳d̳ ̳l̳i̳s̳t̳e̳n̳ ̳t̳o̳ ̳t̳h̳e̳ ̳f̳u̳l̳l̳ ̳e̳p̳i̳s̳o̳d̳e̳ ̳h̳e̳r̳e̳:̳ ̳https://lnkd.in/eW55Y4DR

Don't be reactive; be proactive and keep your processes lean and compliant!
#MedicalDevices #SoftwareAsAMedicalDevice #SaMD #RegulatoryAffairs #QualityManagement #MedTech #SmartEye

If you want to become a LEAD AUDITOR I really advice you to listen to this episode with Rob Packard
🤩 

#medicaldevice #regulatoryaffairs #easymedicaldevice

🎙️ 𝑵𝒆𝒘 𝑷𝒐𝒅𝒄𝒂𝒔𝒕 𝑬𝒑𝒊𝒔𝒐𝒅𝒆 — 𝑯𝒐𝒘 𝒕𝒐 𝑩𝒆𝒄𝒐𝒎𝒆 𝒂 𝑳𝒆𝒂𝒅 𝑨𝒖𝒅𝒊𝒕𝒐𝒓 (𝑴𝒂𝒅𝒆 𝑬𝒂𝒔𝒚!)

If you’ve ever wondered what it really takes to become a Lead Auditor in the medical device industry, this episode breaks it down step-by-step.

We cover:
 ✅ What a Lead Auditor actually is
 ✅ Internal, supplier, and certification audits
 ✅ Who can qualify as a Lead Auditor
 ✅ What you must learn: ISO 19011, ISO 13485, ISO 14971, software audits…
 ✅ Whether lead auditor certifications expire
 ✅ And a full overview of the upcoming Lead Auditor Training by Medical Device Academy, Inc.

This episode is a great starting point for QA/RA professionals, quality managers, consultants, and anyone preparing to lead audits confidently.

👉 Training info & registration: https://lnkd.in/e6JKV34A
For full episode, Check: https://lnkd.in/e9DD5fkP

Monir El Azzouzi Rob Packard


#LeadAuditor #MedicalDevices #ISO13485  #ISO14971 #RegulatoryAffairs #QualityManagement #QMS

Do you plan Clinical Investigation to be done in the UK. Here are the steps you should follow. I hope this will help you.

#medicaldevices #UKCA #clinicalinvestigation #easymedicaldevice

Guide to MHRA Clinical

🇬🇧 𝑵𝒆𝒘: 𝒀𝒐𝒖𝒓 𝑪𝒐𝒎𝒑𝒍𝒆𝒕𝒆 𝑮𝒖𝒊𝒅𝒆 𝒕𝒐 𝑴𝑯𝑹𝑨 𝑪𝒍𝒊𝒏𝒊𝒄𝒂𝒍 𝑰𝒏𝒗𝒆𝒔𝒕𝒊𝒈𝒂𝒕𝒊𝒐𝒏𝒔 𝒇𝒐𝒓 𝑴𝒆𝒅𝒊𝒄𝒂𝒍 𝑫𝒆𝒗𝒊𝒄𝒆𝒔

I’m excited to share an excellent visual guide that walks through the full MHRA clinical investigation pathway for medical devices — from pre-submission to final decision.
 This document is a must-have for anyone working in Regulatory Affairs, Clinical Affairs, or Quality and navigating UK approvals.
Here are some key highlights from the file:
🔹 1. Choose Your Regulatory Route: GB vs Northern Ireland
The guide clearly explains the two pathways (page 2):
Great Britain (GB) → governed by UK MDR 2002
Northern Ireland (NI) → aligned with the EU MDR under the NI Protocol
Each pathway has different rules, timelines, and review clocks, which are summarized visually.
🔹 2. Pre-Application Toolkit
On page 3, the MHRA lists all essential documents you must prepare:
Guidance for Manufacturers
Clinical Investigation Application Checklist
Specific guidance (biological safety, usability, electrical, etc.)
 Plus: the option to request a Regulatory Advice Meeting.
🔹 3. Costs, Fees & SME Benefits
Page 4 outlines standard fees and important SME reductions — including the Pilot Programme for fee waivers for innovative devices.
 A detail not to miss: MHRA will not begin regulatory review until payment is received.
🔹 4. Clear Review Timelines
Both pathways include structured review phases:
GB Pathway → 60-day timeline (page 5)
NI Pathway → 45 or 65 days depending on expert consultation (page 6)
 The guide includes easy-to-read graphics on how the “clock stops” and when sponsors must respond.
🔹 5. Reporting Obligations During the Trial
Pages 7–8 summarize everything you must report:
Serious Adverse Events (SAEs)
Quarterly safety reports
Protocol deviations
 Each pathway uses different rules (GB vs EU MDR requirements).
🔹 6. How to manage amendments
Page 9 distinguishes clearly between substantial vs non-substantial modifications, with different processes for GB and NI.
🔹 7. Ending the Investigation
Page 10 explains obligations for:
Final end-of-study reports
Early termination
Temporary halts
🔹 8. Special Pathway: Combined Review
For CTIMPs + device trials, page 11 outlines the single coordinated MHRA + Ethics Committee route, a huge benefit for complex studies.
📄 Why this document matters
This guide provides:
 ✔ A comprehensive, visual overview
 ✔ Clear step-by-step instructions
 ✔ Practical checklists
 ✔ Direct links to MHRA critical templates and portals
Whether you're preparing your first UK submission or optimizing your process, this file is a powerful resource.

𝐔𝐃𝐈-𝐃𝐈 𝐚𝐧𝐝 𝐔𝐃𝐈-𝐏𝐈 𝐩𝐫𝐢𝐧𝐭𝐢𝐧𝐠 𝐟𝐨𝐫 𝐲𝐨𝐮𝐫 𝐬𝐦𝐚𝐥𝐥 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧
Should you purchase an expensive MRP?
Should you hire an expensive consultant?
Should you make a 30 years loan at your bank???

NO ⛔ 

We just closed a call with a client and he was really happy that we can provide the solution within our tool EasyIFU

If you need to produce labels with the right information and also with the dynamic information UDI-PI then try EASYIFU.COM as we are offering this within our tool. Instead of using it for eIFU, you can also use it for LABEL creation. So don't hesitate to try it and ask us if you need help.

#medicaldevice #regulatoryaffairs #easyifu #udi

𝐓𝐡𝐞 𝐄𝐔 𝐡𝐚𝐬 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐢𝐭 𝐐&𝐀 𝐨𝐧 𝐃𝐫𝐮𝐠 𝐃𝐞𝐯𝐢𝐜𝐞 𝐜𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 which include also Companion Diagnostics. So check at this link the document which again is an update. Only few questions were added. But always good to stay up-to-date.
♾️ https://lnkd.in/eFsUwEXm

🤩 And additionally, I created this Infographic to summarize the content of the document and help you within one picture to understand the concept of Combination Products with Drug-Device. 💯 

𝑰𝒇 𝒚𝒐𝒖 𝒂𝒓𝒆 𝒓𝒆𝒂𝒅𝒊𝒏𝒈 𝒖𝒏𝒕𝒊𝒍 𝒉𝒆𝒓𝒆, 𝑰 𝒎𝒂𝒚𝒃𝒆 𝒉𝒂𝒗𝒆 𝒂 𝒒𝒖𝒆𝒔𝒕𝒊𝒐𝒏 𝒇𝒐𝒓 𝒚𝒐𝒖. 𝑯𝒂𝒗𝒆 𝒚𝒐𝒖 𝒆𝒗𝒆𝒓 𝒂𝒔𝒌𝒆𝒅 𝒂 𝑵𝒐𝒕𝒊𝒇𝒊𝒆𝒅 𝑩𝒐𝒅𝒚 𝒇𝒐𝒓 𝒂𝒏 𝒐𝒑𝒊𝒏𝒊𝒐𝒏 𝒍𝒆𝒕𝒕𝒆𝒓 𝒂𝒏𝒅 𝒊𝒇 𝒚𝒆𝒔, 𝒉𝒐𝒘 𝒘𝒂𝒔 𝒚𝒐𝒖𝒓 𝒆𝒙𝒑𝒆𝒓𝒊𝒆𝒏𝒄𝒆 𝒐𝒓 𝒕𝒉𝒆 𝒄𝒉𝒂𝒍𝒍𝒆𝒏𝒈𝒆𝒔 𝒚𝒐𝒖 𝒆𝒏𝒄𝒐𝒖𝒕𝒆𝒓𝒆𝒅?
👏 Cheers

#medicaldevice #easymedicaldevice #regulatoryaffairs

EU Drug Device Combination Infographic Easy Medical Device

And you?
Are you also activating your Regulatory Survival Mode during an Audit? 🤣

MY MIND DURING AUDITS 🧠📊
 🔵 Compliance: 2%
 🟠 Survival: 98%

Because between opening traceability files, answering “just one more question,” and looking confident while internally screaming… the real KPI is making it to the closing meeting alive 😅
All auditors see: calm & collected.
 What’s really happening: pure regulatory survival mode activated.

#AuditLife #QARAHumor #MedicalDevices #ISO13485 #MDR

Check our latest discussion with Rob Packard on Lead Auditor training. Learn how you can become a Lead Auditor.
#medicaldevice #easymedicaldevice #regulatoryaffairs

🔔 𝑹𝒆𝒎𝒊𝒏𝒅𝒆𝒓 — 𝑵𝒆𝒘 𝑷𝒐𝒅𝒄𝒂𝒔𝒕 𝑬𝒑𝒊𝒔𝒐𝒅𝒆: 𝑩𝒆𝒄𝒐𝒎𝒆 𝒂 𝑳𝒆𝒂𝒅 𝑨𝒖𝒅𝒊𝒕𝒐𝒓 (𝑴𝒂𝒅𝒆 𝑬𝒂𝒔𝒚!)
If you haven’t listened yet, our latest episode breaks down everything you need to know to become a Lead Auditor in the medical device industry — in a practical, simplified way.
🎧 Catch up on the episode here:
 👉 https://lnkd.in/e9DD5fkP
🎓 And don’t forget: Registration is open for the upcoming Lead Auditor Training by Medical Device Academy, Inc.
 This is one of the most complete and hands-on courses available today.
👉 Training details & registration: https://lnkd.in/e6JKV34A
Whether you're in QA/RA, consulting, manufacturing, or preparing for your next career step, this episode and training are a solid opportunity to level up your auditing skills.
Monir El Azzouzi Rob Packard

#LeadAuditor #MedicalDevices #QualityTraining #ISO13485 #RegulatoryAffairs #QualityManagement #QMS

Check last Regulatory Update for 2025. We will talk about a lot of important topics so get this 30 minute summary which will save you few hours.
#medicaldevice #regulatoryaffairs #easymedicaldevice #podcast

𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐍𝐞𝐰𝐬 𝑫𝑬𝑪𝑬𝑴𝑩𝑬𝑹 𝟐𝟎𝟐𝟓 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞-𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐊𝐧𝐨𝐰

A quick roundup of the most important regulatory and industry news:
🇪🇺 Europe
48% of EU medical devices face availability disruptions — major challenges ahead for manufacturers.
SCHEER opens consultation on the safety of non-medical brain stimulators.
New revision of the Q&A on medicines used with medical devices (new clarifications added).
EUDAMED becomes mandatory in May 2026 — a major milestone for MDR/IVDR implementation.
🇬🇧 UK
MHRA strengthens its advisory framework — but shifts away from open consultations.
📘 Standards
ISO 10993-1 update: risk-based evaluation becomes the new normal.
ISO 18969 draft open for comments — digital documentation and IFUs in focus.
🌍 Rest of the World
Argentina introduces a simplified pathway for Class I/II devices.
Canada advances MDEL modernization + updates licensing guidance.
Brazil moves toward full digitalization of device certificates.
🎧 Podcast Highlights
The journey of a CRO
What’s changing with ISO 10993-1
How to become a Lead Auditor
MedTech is moving fast — stay informed, stay compliant, and stay ahead.
For full episode, Check: https://lnkd.in/dd6GNQCx

Monir El Azzouzi 

#MedTech #RegulatoryAffairs #MedicalDevices #EUDAMED #ISO10993
#QualityManagement #Healthcare #ClinicalResearch #Compliance

Do you need an accredited training to be an Auditor?
Check this with Rob Packard

🎓 𝐀𝐜𝐜𝐫𝐞𝐝𝐢𝐭𝐞𝐝 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠… 𝐓𝐚𝐮𝐠𝐡𝐭 𝐛𝐲 𝐍𝐨𝐧-𝐀𝐮𝐝𝐢𝐭𝐨𝐫𝐬?

 Many QA/RA professionals don’t realize this:
 Even “accredited” auditor trainings are sometimes delivered by instructors who have never performed a certification body audit.
If all your training comes from uncontrolled or non-accredited environments—even big companies like Pfizer or Abbott—you may still need to start from zero when entering an accredited pathway.
The shocking part?
 Some accredited programs are taught by trainers who have never conducted an accreditation audit themselves.
👉 A powerful reminder:
 Accreditation is about competence, not branding.
 Always check who is teaching you… and what real audit experience they have.
Monir El Azzouzi Rob Packard
#Auditing #LeadAuditor #QualityManagement #ISO13485 #MedicalDevices #Training #Compliance #RegulatoryAffairs

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