Medical Device made Easy Podcast

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.In this podcast episode, we explore:🔹 What is a Lead Auditor?The responsibilities, authority, and role differences between internal audits, supplier audits, and certification audits.🔹 Who can become a Lead Auditor?The competencies required, background expectations, and what makes a good auditor.🔹 What you must learn to be effective:ISO 19011 — the core auditing guidelineISO 13485 — the medical device QMS standardISO 14971 — risk management for medical devicesSoftware lifecycle & technical documentation considerations🔹 Do Lead Auditor certificates expire?Clarifying the myth around renewal, competency maintenance, and the expectations of certification bodies.🔹 Spotlight: Lead Auditor Training by Medical Device AcademyWe review the upcoming training course, covering:Curriculum and learning objectivesExam formatPrerequisitesPricingTraining datesCertificate details👉 Learn more or register here: https://medicaldeviceacademy.com/lead-auditor-training/This episode is ideal for QA/RA specialists, QMS managers, consultants, and anyone aiming to take a leadership role in medical device auditing.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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

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 Daineko, 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 revisionWhy the new version is best seen as an evolution, not a revolutionHow the standard pushes further into a risk-based, scientifically justified approachThe link with ISO 14971 and lifecycle thinkingChanges in contact categorization and cumulative exposureThe industry trend toward reducing animal testing through in vitro methods and data-driven justificationHow to conduct a gap analysis once the new standard is publishedPractical advice on how to prioritize updates without freezing projects or panickingReal-world examples where process chemicals, not base materials, changed the risk pictureHow Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices👉 If you’re involved in RA/QA, R&D, toxicology, or clinical development, this conversation gives you a practical roadmap for navigating the transition to the new ISO 10993-1.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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.LinksMarina Daineko Linkedin: https://www.linkedin.com/in/marinadaineko/Intrinsic Medical Group, LLC: https://www.linkedin.com/company/intrinsic-medical-group/posts/?feedView=allSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

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 pitfalls and real-life examples Working with Notified Bodies and new expectations under MDR Lessons from projects that didn’t go as planned The crucial alignment between clinical data and human factors Practical advice for startups on avoiding top regulatory mistakes Her vision of the future: RWE, adaptive study designs, digital health & greater regulatory convergence Links: Helene Quie: https://www.linkedin.com/in/helene-quie-863a323/ Qmed Consulting: https://qmed-consulting.com/ 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248 Dedicated proportionate regulatory pathway for Niche fields Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products) Update of MDCG guidance on In-house devices to better reflect the operational reality. Off-label use and RUO are not falling on Article 5.5 so grey zone.   Team-NB proposal for MDR & IVDR - 5 topics on the agenda:  https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/ Early dialogue: Use of this to talk to Notified Bodies Article 61.10 & WET: Update for more clarity. Narrow the scope. Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing. Coding for MD and IVD Designation and recertification: For Notified Bodies Breakthrough: Coordinated pathway with challenge to generate Clinical Data. Notified Bodies Count - S New comers for MDR and IVDR:  SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921 ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1 Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121 Standards New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078 Biocompatibility ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai Service eIFU with free access -Test it and let us know : https://Easyifu.com eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/ Magazine eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/ ROW US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download   PODCAST Podcast review -  What happened in October 2025 Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/ Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/ Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/ Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/ Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh:  https://podcast.easymedicaldevice.com/361-2/

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 hallucination How to use AI safely and ethically in regulated environments 👉 By the end, you’ll know how to build smart workflows that save time, ensure compliance, and keep human oversight where it matters most. 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take 💡 Rob also shares practical advice for manufacturers seeking FDA support during this period, as well as insights into how his team can assist in maintaining compliance and communication continuity. If you’re part of the medical device ecosystem — this is essential reading. Tags: FDA, Medical Devices, Regulatory Compliance, Quality Management, US Government Shutdown, Rob Packard, Clinical Trials 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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) How EU MDR uses RWE through PMCF and PMS The key differences in approach between the two regions A practical 5-step roadmap to build a compliant RWE strategy Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them 💡 Whether you’re in Regulatory Affairs, Clinical Affairs, or Quality Assurance, this episode gives you a clear framework to make Real-World Evidence a competitive advantage, not a compliance headache. 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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 Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system Maintaining a “living” Clinical Evaluation Report across the device lifecycle 👉 By following this checklist, you’ll not only pass your next review but also strengthen your evidence strategy for long-term compliance. 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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 environmental responsibility Software and AI in clinical investigations, and the use of real-world data Global market access – EU vs US pathways and MDSAP recognition Technical deep dives into ISO 13485, biocompatibility, usability, and cybersecurity The consensus was clear: regulatory pressure is increasing, but collaboration, innovation, and anticipation remain the keys to success. 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links Site web larentreedudm: https://www.larentreedudm.com Linkedin poste: https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381678647151112192-WQqX?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQhttps://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381670070097297408-80sP?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381641922739609600-HXhq?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381639827718447104-SQs-?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-regulatoryaffairs-easymedicaldevice-activity-7381629520535060480-kJ0p?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevices-regulatoryaffairs-easymedicaldevice-activity-7381602405030711296-aHcv?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Medboard Europe TToo 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_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system   EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf   UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report   Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?:  https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf   Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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 Regulatory frameworks: EU MDR/IVDR, FDA’s PCCP, IMDRF guidelines Supplier and infrastructure considerations A step-by-step PMS workflow for QA/RA teams Real-world case study on AI performance drift 👉 We conclude with a practical checklist to help QA/RA teams ensure compliance while keeping patients safe. 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical Innovation 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 deep commitment to education. A Career Built on Medical Breakthroughs Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide. Why a Surgeon Became a CEO Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice. As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career. Patient Education as a Driving Force Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most. By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership. Building a Global Legacy Through Training Prof. Possover’s passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach. This dedication reflects a philosophy that medicine’s greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations. Lessons for Medical Professionals and Entrepreneurs This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business. Clinical expertise can fuel entrepreneurship when paired with strategic thinking. Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand. Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers. Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover’s journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership. In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage. Links INSP Link: https://isnp.possover.com/index neurogyn: https://neurogyn.com/ Possover: https://www.possover.com/en/ Youtube: https://www.youtube.com/results?search_query=marc+possover Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice  

bersecurity 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…) Managing supplier and open-source component risks Implementing and maintaining an SBOM Key trends like the NIS2 Directive and the EU AI Act 👉 We finish with a practical checklist for QA/RA teams to assess their readiness today. Cybersecurity isn’t about perfection—it’s about showing regulators you are in control. 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 Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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 issued, especially for IVDs. Time for certification: between 13 to 18 months on average Delay due to application missing critical information and refusal due to submission outside NB scope No transparency on capacity Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770If device emit radiation and need clinical investigation in germany: Include a radiation risk assessment in your clinical investigation dossier Coordinate with Radiation protection authorities Update investigator brochure and patient information Stricter Monitoring & Reporting Impact on Timelines So stricter documentation, more authorities involved and longer approval times   UK MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout  -  https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device   Switzerland New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html 1 july-2026   Magazine Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1   Podcast: Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/   REST OF THE WORLD SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it:  USA: PCCP - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139 TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/ Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf  

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 using AI in regulatory compliance. Together, they discuss: Why more QA/RA teams are experimenting with AI tools like ChatGPT, Gemini, Claude, and Grok How to integrate AI into different product design and regulatory phases The role of Prompt Engineering and why it matters in compliance Practical tips for creating effective AI prompts The warnings and risks you should keep in mind when relying on AI How agencies like the FDA are beginning to explore AI for dossier reviews 👉 If you want to stay ahead in the world of medical device compliance, this conversation is a must-li

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: Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of semantic versioning in regulated environments. Documentation & traceability – Why proper version control and documentation are essential for audits and compliance. Communication with stakeholders – Best practices for release notes, change logs, and informing users, regulators, and internal teams. Common pitfalls – Mistakes that lead to compliance risks and how to avoid them. Pro tips & resources – Actionable recommendations to strengthen your update and versioning strategy. Whether you are a software engineer, QA/RA professional, or regulatory affairs manager, this episode will give you practical tools and insights to build a robust, compliant, and audit-ready update process. 👉 Listen now and discover how to master the balance between innovation, safety, and compliance in medical device software.

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 Use networking (both in-person and online) to grow Balance expertise with passion to create real impact For anyone starting out—or looking to strengthen client relationships—this is your roadmap from zero to one.

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 thriving consultancy business — all without traditional advertising. What you’ll discover in this episode: 📈 How Adam transitioned into RAQA with no previous background ✅ The real day-to-day life of an ISO 13485 auditor — separating myths from reality ⚠️ Common mistakes consultants and auditors should avoid 🤝 What clients truly value when hiring a consultant 🚀 How to grow your consulting business organically 🤖 Adam’s next big step: creating an AI-powered audit tool to transform compliance work Whether you’re just starting your career in medical devices or thinking about launching your own consultancy, this episode offers honest, practical insights you won’t find in any textbook. 🎧 Listen now and gain a realistic perspective on what it takes to succeed in the highly regulated MedTech industry.

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 ask the money question!) Whether promoting open positions is still a challenge in 2025 Mitch’s personal journey—education, family, and the struggles of building a business from scratch What he would do differently if he had to start again Whether you're considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go "from zero to one." 👉 Listen now and subscribe to our podcast to never miss a new episode! Linkedin: https://www.linkedin.com/in/mitchrobbins/ Website: https://theanthonymichaelgroup.com/

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 covered by transitional provisions and even non-medical products listed under Annex XVI. This shift marks a turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU. 🔎 What the regulation says: Manufacturers are allowed to provide eIFUs for professional-use devices, as long as the device is not likely to be used by laypersons. For any device that might be used at home or by a non-professional, a paper IFU is still mandatory. All versions of an eIFU—current and obsolete—must be hosted securely and remain accessible to authorities on request. The URL of the eIFU must be registered in EUDAMED's UDI database once that requirement becomes mandatory. 📌 Top 5 reasons why switching to eIFU makes sense: Broader regulatory permission This update grants manufacturers the freedom to digitize IFUs across their entire product line, simplifying regulatory planning and execution. Significant cost savings and faster updates With eIFUs, there’s no need for printing, translation management across packaging batches, or physical distribution—everything can be updated instantly online, cutting costs and time-to-market. Improved traceability and audit readiness Digitally managing eIFUs ensures version control, easy access for auditors, and a clean digital trail that supports internal QA systems. Better experience for healthcare professionals Healthcare professionals prefer electronic formats for their speed, searchability, and multilingual options—making your devices more user-friendly. Alignment with the EU’s digital vision By linking eIFUs directly with EUDAMED and UDI databases, you align your business with the evolving regulatory ecosystem and future-proof your documentation process. 🛑 But eIFU is not a one-size-fits-all solution. You still need paper IFUs in key scenarios: If your device could be used by laypersons, you must provide a paper version. In low-connectivity settings, such as field hospitals or rural clinics, physical IFUs may be more reliable. Adopting eIFU requires full platform readiness, including hosting, backups, multilingual versions, and internal QA validation. Regulatory responsibility is now entirely on the manufacturer—including website uptime, version archives, and EUDAMED linkage. Some stakeholders—including auditors and hospitals—still prefer traditional paper documentation, which could delay full adoption. 📽️ Watch our video to get a complete overview of the regulation and see how EasyIFU helps you implement a compliant, secure, and future-ready eIFU process. This is essential for RA/QA teams, product managers, and any manufacturer operating under MDR.