The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions. Will we need to retest everything? Is this a complete game-changer, or just an evolution? How will Notified Bodies and the FDA react? In this episode of the Medical Device Made Easy Podcast , Monir El Azzouzi hosts Marina Dainek o, biocompatibility consultant at Intrinsic Medical Group , to unpack what’s really coming. This episode covers: The background and current status of the ISO 10993-1...
Nov 27, 2025
In this long-form interview, Helene Quie , founder of Qmed Consulting , shares an inside look at nearly 20 years of experience in clinical and regulatory consulting for medical devices. This article covers: Helene’s personal journey from employee to entrepreneur The early risks and decisions that shaped Qmed’s growth How the company’s services and markets evolved over time A deep dive into clinical evidence generation vs equivalence The seismic impact of EU MDR on clinical strategies PMCF pitfal...
Nov 20, 2025
MedBoard EU Joint clinical assessment procedure – EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086 Team-NB position paper on Companion diagnostics – Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf MDR and IVDR put at risk transplantation – Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%...
Nov 12, 2025
Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs . In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be handled carefully. We discuss: The reality behind “AI replacing QA/RA jobs” Key tools: n8n , Make , Zapier , OpenAI , and OpenFDA Building automation workflows for regulatory monitoring and documentation Managing data privacy , confidentiality , and local vs cloud solutions The cost, setup time, and risks of AI halluc...
Nov 05, 2025
US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers , the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You’ll learn: Which FDA activities continue, and which are suspended How submissions like 510(k) ...
Oct 30, 2025
Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR , and how you can design a compliant, global strategy that turns data into regulatory strength. You’ll learn: What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE) How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA) ...
Oct 23, 2025
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities. This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them: Understanding the shift from MDD to MDR (Article 61 & Annex XIV) Why weak Clinical Evaluation Plans (CEPs) lead to rejection How to generate and analyze real, device-specific clinical data In...
Oct 16, 2025
The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation. Main themes included: Updates on EU MDR/IVDR and new regulatory initiatives in France Structured dialogue with Notified Bodies and the harmonization of technical documentation Post-market discontinuation and the importance of anticipation for patient safety Eco-design and sustainability , bridging healthcare and ...
Oct 09, 2025
Medboard Europe Too much Incomplete Tech File – Let’s explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI – Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update – New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline...
Oct 01, 2025
Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware. In this article, based on the podcast episode, we cover: How PMS differs for software, cloud, and AI-based devices Usage monitoring & anomaly detection through dashboards and KPIs Revalidation of updates and retrained AI algorithms Re...
Sep 24, 2025
The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover , this evolution felt like a natural extension of his life’s mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery. In this exclusive episode of the Medical Device Made Easy Podcast , host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a dee...
Sep 18, 2025
Cybersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence. In this article (based on the podcast episode), we explore: How to prepare cybersecurity documentation for audits and inspections Building post-market processes for vulnerability handling and reporting Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…) ...
Sep 10, 2025
Medboard EUROPE Guidance on the implementation of the Master UDI-DI – MDCG 2024-14 – rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf Updated – Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf There’s a significant backlog: far more applications submitted than certificates...
Sep 04, 2025
Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does this mean for compliance professionals? Is AI a powerful tool to accelerate regulatory processes, or a risky shortcut that could jeopardize compliance? In this new episode of the Medical Device Made Easy Podcast , Monir El Azzouzi sits down with RJ Kedziora (Estenda) to explore the opportunities and risks of usin...
Aug 28, 2025
Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks —they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304 . In this episode of our podcast, we dive into the critical aspects of software update management for medical devices :...
Aug 21, 2025
From Zero to One: Mastering Client Collaboration in Consulting Starting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical Device Made Easy podcast, I share my personal path: from my early days in engineering to creating Simply Medica, and the lessons learned along the way. We discuss how to: Build credibility before calling yourself a consultant Turn your first project into a stream of referrals U...
Aug 14, 2025
Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor ? In this episode of the Medical Device Made Easy Podcast , I sit down with Adam Isaac , an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world. Adam’s journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA) , he navigated the complex world of compliance and built a ...
Aug 08, 2025
In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you’re a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice. What you’ll learn: Why Mitch chose to specialize in QA/RA The tension between client expectations and candidate realities How recruiters make their revenue (yes, we...
Jul 31, 2025
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory update— EU 2025/1234 —comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices , including those covere...
Jul 24, 2025
Quality & Regulatory in MedTech – Interview with Pardeep Kaur Background: From IT in India to MedTech in Norway You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?) What were the biggest challenges whe...
Jul 17, 2025
Guest: Stefan Bolleininger Title: From Zero to One: Creating your Consulting Firm Logo: Be on Quality Telling the story behind Be on Quality, the challenges for you, the way you did grow the business, the things you would do differently cost Sharing also the life of a CEO that did start this project. How many hours are you working, zis it easy to disconnect, what are your fears…. AI What’s next for Be on Quality Link: Be on Quality: https://www.be-on-quality.com/ Stefan Bolleininger Linkedin: ht...
Jul 10, 2025
Medboard: https://www.medboard.com/ EUROPE new eIFU rules – Let’s save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en EasyIFU.com MDR + IVDR + AI Act = MDCG 2025-6 – Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf MDCG 2025-5: IVD...
Jul 03, 2025
From Zero to One: SaaS Founder’s First Five Years with Ivan Perez Chamorro In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the CEO and founder of Medboard, a fast-growing SaaS company. Ivan takes us behind the scenes of his entrepreneurial journey, from starting with zero to building a thriving business in the tech world. In this candid conversation, Ivan dives into: The story behind Medboard and how it all began from scratch The challenges he faced a...
Jun 25, 2025
Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does Risk Management mistakes that could cost you your certification! In this episode of the Medical Device Made Easy Podcast , Monir El Azzouzi tackles one of the most common and preventable Notified Body non-conformities : flawed risk grading strategies. If your team is still using overcomplicated matrices or adjusting severity post-mitigation — this episode is your wake-up call . W...
Jun 18, 2025
Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cover: Why testing matters : Real-world examples of what can go wrong (and how to avoid it) From user needs to test cases : Simple “if-then” steps you can try today Who should test : Pros and cons of in-house vs. external testers eQMS basics : How to validate your electronic Quality Management System wi...
Jun 12, 2025
Europe Notified Body survey report – 31 October 2024 – What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf The MIR form has been updated – Version 7.3.1 – Don’t use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en UK UK MIR and FSCA – Change is in the AIR: https://www....
Jun 04, 2025
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as...
May 28, 2025
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification. Who is Carmen Bellebna ? Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutio...
May 22, 2025
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode. Who is Cecile van der Heijden ? Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in le...
May 15, 2025
In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we’ll let you know when and why you should involve them earlier. Listen to this episode. Who is Aouda Ou...
May 07, 2025
