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: [email protected]

Authorized Representative: [email protected]

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.

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: [email protected]

 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/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.

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 Impact
The 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: [email protected]

🌍 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.

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.

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.

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.

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.

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.

Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field?

In this episode of the Medical Device Made Easy podcast, Monir El Azzouzi interviews Florian Tolkmitt, Clinical Evaluation Expert at Pro-Liance, to explore his journey from engineering into clinical evaluation and regulatory science.

The discussion covers:

Florian’s education and early career path

How he specialized in Clinical Evaluation

Key lessons learned since the implementation of the EU MDR

What Notified Bodies really expect from clinical documentation

Frequent mistakes manufacturers make in clinical submissions

The evolving role of consultants in supporting compliance

How AI and digital tools may transform literature review and evidence generation

Advice for young professionals entering the MedTech field

This episode offers practical insights, career inspiration, and forward-looking perspectives for anyone working — or aspiring to work — in clinical evaluation and regulatory affairs.

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

Linkedin florian: https://www.linkedin.com/in/florian-tolkmitt-clinical-evaluation/

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.

Medboard

Europe

48% disruption in the EU - I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97fd_en?filename=md_availability_study_presentation_2024.pdf

Consultation: SCHEER asks you - Are Brain Stimulators for non-medical purpose dangerous: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-scientific-opinion-health-hazards-and-risks-associated-use_en

Q&A Medicines used with Medical Devices - Revision 6 with new questions: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf

EUDAMED is Mandatory - From 28 May 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502371 - https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en

UK

Better Call MHRA - But we don't consult: https://www.gov.uk/guidance/medical-devices-get-regulatory-advice-from-the-mhra

Standard

ISO 10993-1 mutation - Nothing is automatic anymore: https://www.youtube.com/watch?v=AkSZVNSz5a0

ISO 18969 draft -  Comments until 28-01-2026: https://www.youtube.com/watch?v=zCR9HlHJ5l0

EasyIFU

Create your Labels with EasyIFU - UDI included: https://easyifu.com

Rest of the World

Argentina

Argentina: Simplified application - Class I/A or Class II/B: https://www.argentina.gob.ar/noticias/anmat-establece-un-regimen-simplificado-para-la-habilitacion-de-establecimientos

Canada

Canada: Modernization of the MDEL - Some changes: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-modernizing-mdel-framework-phase-ii.html

Canada: Medical Device License Application - Guidance on how to do it: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses.html

Brazil

Brazil: Digitalisation of Certificates - You can request that online now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-lanca-nova-ferramenta-para-emitir-certificados-de-dispositivos-medicos

Podcast

Podcast Nostalgia - Let's review previous podcasts

Episode 363 - The journey of a CRO with Helene Quie: https://podcast.easymedicaldevice.com/363-2/

Episode 364 - What is changing with the new ISO 10993-1 with Marina Daineko: https://podcast.easymedicaldevice.com/364-2/

Episode 365 - How to become a Lead Auditor with Rob Packard: https://podcast.easymedicaldevice.com/365-2/

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.