Medical Device made Easy Podcast

easymedicaldevice

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter. This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

  1. Medical Device News February 2026 Regulatory Update

    5D AGO

    Medical Device News February 2026 Regulatory Update

    SPONSOR Medboard: https://www.medboard.com/ EUROPE  New Harmonization Standards -  Implementing Decision 2026/193:  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193 Neurosurgical implants EN ISO 14155:2020 on clinical investigations EN ISO 18562 series on Biocompatibility for Breathing gas pathways   Germany: Transition from DMIDS to EUDAMED - March 19, 2026: https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026     High-Level Conference on Medical Devices - March 16th, 2026 - Brussels: https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_en The conference will feature three breakout sessions focusing on: Enhanced predictability for conformity assessments: combining certainty with flexibility Clinical evidence at EU level to support the regulatory framework: the key role of Expert Panels Breakthrough technologies for better care: turning guidance into reality Team-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf Switzerland Swissmedic inspection on Importers -30 importers, 232 product samples, RESULT?: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf   Swissdamed Webinar - May 28th, 2026: https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.html UK UK to exempt Health Institution - Not a priority for now https://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devices Training Team-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026: https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/ EasyIFU Create eIFU and Labels easily - Compliance to EU MDR/IVDR: Https://easyifu.com RoW North America FDA: General Wellness devices - Guidance by the FDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices FDA: Cybersecurity in Medical Devices - QMS and Pre-market submission: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket APAC Malaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificates https://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysia India: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3D Africa Egypt: Database for Product Registration -Online Electronic Service:  https://eservicesdata.edaegypt.gov.eg/MedicalDevices Middle East Saudi Arabia: SFDA inspection of QMS requirements - Process that would be followed: https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdf Podcast Episode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/ Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/ Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ Services Consulting support: info@easymedicaldevice.com Authorized Representative: EO@easymedicaldevice.com 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 This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    34 min
  2. Validation & Supplier Management in MedTech

    FEB 5

    Validation & Supplier Management in MedTech

    Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development. Key topics discussed include: Test Method Validation: definition, regulatory expectations, and when it is required FDA warning letters and the risks of non-compliant validation approaches Common pitfalls and best practices for Test Method Validation Process Validation and Packaging Validation The role of statistics in MedTech, including sample size justification Risk management linked to validation activities Supplier management, from sourcing components to audits and long-term supplier development Simon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on: Process validation and equipment qualification Test Method Validation training ISO 13485 and 21 CFR 820.30 compliance Supply chain development, including injection molding and cleanroom manufacturing environments This episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com  If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well. Link Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    39 min
  3. QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026

    JAN 28

    QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026

    For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.But starting February 2nd, 2026, FDA will implement QMSR, changing not only the regulation structure but also the inspection philosophy. QMSR does not eliminate Part 820. Instead, FDA is amending it to incorporate ISO 13485:2016 by reference, bringing the US closer to the global quality language used across Europe, Canada, Japan, and beyond. Why FDA is doing this FDA’s move is driven by three key goals: Harmonization (reduce duplicated systems and audits) Modern quality thinking (move from “procedures” to “system effectiveness and risk”) Inspection efficiency (more end-to-end audits) What inspections may look like under QMSR Instead of jumping between SOPs, inspections may follow real flows like:Complaint → Risk Management → CAPA → Design Change → Supplier ImpactThe focus becomes traceability, consistency, and risk-based justification. What companies should do now To be QMSR-ready, companies should: Build an ISO 13485-style process map Make risk visible everywhere, not only in product development Improve CAPA triage and effectiveness checks Strengthen design controls (especially software development & V&V) Train teams on the new “why/how” inspection style Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  📩 If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com 🌍 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well. 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 This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    17 min
  4. How to Remediate a Design History File (DHF)

    JAN 22

    How to Remediate a Design History File (DHF)

    Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes. In this podcast episode, we provide a structured and practical discussion on: The definition and purpose of a DHF Key differences between FDA QMSR and ISO 13485 requirements How the DHF concept is addressed within ISO 13485 When DHF remediation becomes unavoidable Typical causes of remediation, including accumulated DHF debt How to remediate a DHF without creating new compliance risks Common pitfalls and practices to avoid How to define a realistic and defensible remediation strategy Regulatory communication considerations with: National Competent Authorities Notified Bodies   This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way. If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach. Links Richie Christian Linkedin: https://www.linkedin.com/in/christianrichie/ https://www.wega-it.com/remediation-of-medical-device-design-history-file/ 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 This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    32 min
  5. Medical Device News January 2026 Regulatory Update

    JAN 15

    Medical Device News January 2026 Regulatory Update

    Medboard: https://www.medboard.com/ Europe EMD Mag Issue 3 - For QA RA people: https://easymedicaldevice.com/emd-mag/ EU to simplify MDR and IVDR - Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf  -  https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf  -  https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdf Team NB Position Paper on Annex VII - Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdf MDCG 2025-9 Learn Breakthrough Devices BtX - Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf Infographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI MDCG 2025-10 on PMS - Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf Notified Body Malta Conformity Assessment - 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1    Services EasyIFU - Manage your eIFU and Labels: https://easyifu.com   Switzerland Swissdamed registration deadline - July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html - https://swissdamed-webinar.ch/#E402A0 UK MHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees   RoW FDA: How to use Real World Evidence - Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices Australia: Preparing for UDI and AusUDID - Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf   Podcast Podcast Nostalgia - What was discussed lastly:  Episode 367 - From Engineer to Clinical Evaluation Expert - Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/ Episode 368 - Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/ Episode 369 - Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/ Episode 370 - Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/ This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    35 min
  6. Verification & Validation Explained — A Practical Conversation with Aaron Joseph

    JAN 7

    Verification & Validation Explained — A Practical Conversation with Aaron Joseph

    Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams. In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better. Throughout the discussion, we cover: A clear, simple explanation of Verification vs. Validation Why V&V must span the entire development lifecycle How poor requirements create downstream V&V failures The risks of starting V&V planning too late How to simplify test methods without losing rigor Practical strategies for handling failed tests How to think about traceability without fear The future of V&V as software and AI become more prevalent This episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes. 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   Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/ 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 This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    42 min
  7. Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next

    12/31/2025

    Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next

    As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026. The episode reflects on a full year of continuous content creation, including: Weekly podcast episodes covering global medical device regulations Increased focus on artificial intelligence and its impact on QA/RA roles Educational initiatives such as EMD Mag, designed to make complex regulatory topics more accessible Development of digital tools like EasyIFU, labeling automation, and eQMS solutions Expansion of consulting, back-office services, and international presence The discussion also addresses upcoming challenges: Increasing pressure on Notified Bodies Risks for late MDR/IVDR transitions The importance of anticipation and regulatory strategy for new and existing manufacturers More than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment. 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 This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    22 min
  8. Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal

    12/24/2025

    Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal

    The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability. In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety. The discussion covers: Key shortcomings of the current MDR/IVDR framework The impact on innovation, availability of devices, and SMEs The eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified Bodies How upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulations This episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly. 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   Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/ 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   This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

    55 min
4.8
out of 5
20 Ratings

About

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter. This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

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