Easy Medical Device Podcast

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA. 

Who is Cyrille Michaud? 

Co-founder and managing partner of MD101 Consulting.
Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices.

Specialties: Software Processes Management.
CE Mark & FDA 510k
21 CFR 820 - ISO 13485 - ISO 14971 - IEC 62304 - IEC 62366 - IEC 60601 - IEC 82304-1 - UL 2900-1 - IEC 81001-5-1
Agile Methods applied to medical device software design.
Cybersecurity applied to medical devices.

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. 

Link

Cyrille Michaud LinkedIn:  https://www.linkedin.com/in/cyrillemichaud/ 

MD101 : www.MD101.io 

Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings 

Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released 

FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity

IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English) 

Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister 

Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now

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 hosted by Podcastics, the easiest platform to create and publish your podcast.

Sponsor: Medboard

Europe

 Certificates under Condition - Team NB press release: https://www.team-nb.org/wp-content/uploads/2025/03/PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312.pdf

European Artificial Intelligence Office -A new expert panel for AI Medical Devices:  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500454

UK invented the AIaMD - Fewer law but more guidance: https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-rhc/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-regulatory-horizons-council

Submit a Clinical Study in Spain and Belgium - Each country decides:

Spain: https://www.aemps.gob.es/informa/la-aemps-detalla-el-procedimiento-para-la-publicacion-de-informes-de-investigaciones-clinicas-con-productos-sanitarios-en-espana/

Belgium: https://www.afmps.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%2011.0_0.pdf

SCHEER - Brain Stimulators - Non-medical purpose use: https://health.ec.europa.eu/latest-updates/scheer-minutes-working-group-meeting-brain-stimulators-19-march-2025-2025-03-28_en

IMDRF Reliance Program - For Regulators but can impact manufacturers: https://www.imdrf.org/sites/default/files/2025-03/IMDRF%20Reliance%20playbook%20draft%20%28final%29.pdfSuccessful Pilot Advice Expert Panel - For high-risk device: https://www.ema.europa.eu/en/documents/report/pilot-advice-expert-panels-manufacturers-high-risk-medical-devices-interim-report-experience-pilot-february-2023-december-2024_en.pdf

Team NB MDR Clinical Training - May 7th 2025: https://www.team-nb.org/wp-content/uploads/2025/03/Leaflet-MDR-Clinical-Manufacturers-Training-20250507.pdf

Registration

Ask Easy Medical Device for Registration - Support most of the world: https://easymedicaldevice.com

ROW

Sex Specific Data in Clinical Study - Do it or?: https://www.fda.gov/media/82005/download

Brazil UDI in Progress - Subtitle: Anvisa consultation is open: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-abre-consulta-publica-sobre-base-de-dados-para-identificacao-unica-de-dispositivos-medicos

Become a Conformity Assessment Body in Malaysia - Notified Body are not automatically Conformity assessment bodies: https://www.mda.gov.my/images/DOC%20UPLOAD/DOC%20UPLOAD%202025/Guidance%20Document%20Conformity%20Assessment%20Body%20CAB%20Guide%20for%20Conducting%20Conformity%20Assessment%20By%20Way%20of%20Verification.pdf

Saudi Arabia ISO 13485 guidance -Looks like an MDSAP structure: https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-G024.pdf

Singapore Cybersecurity Best Practice - Consultation until May 12, 2025: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/best-practices-guide-on-medical-device-cybersecurity_draft-for-consultation.pdf?sfvrsn=8dcfa560_1

Podcast

Episode 328 - What are the TOP 3 FDA inspection issues with Darrin Carlson: https://podcast.easymedicaldevice.com/328-2/

Episode 329 - What if the Notified Body asks you: Is your Software Validated?: https://podcast.easymedicaldevice.com/329-2/

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 hosted by Podcastics, the easiest platform to create and publish your podcast.

https://www.pinterest.com/easymedicaldevice

In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics So stay tuned. 

Who is Tibor Zechmeister? 

Passionate about Creating Maximum Efficiency in MedTech Regulatory | Head of Regulatory and Quality Flinn.ai | Notified Body Auditor | MedTech Entrepreneur | Software Solutions for Regulatory Automation with AI

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. 

Link

Tibor Zechmeister LinkedIn:  https://www.linkedin.com/in/tibor-zechmeister/ 

Flinn.ai Website: https://www.flinn.ai/ 

ISO 13485:2016 https://www.iso.org/standard/59752.html 

ISO/TR 80002-2:2017: https://www.iso.org/standard/60044.html 

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 hosted by Podcastics, the easiest platform to create and publish your podcast.

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned. 

Who is Darrin Carlson? 

Darrin Carlson has over ten years of experience in Quality and Regulatory in the medical device, pharmaceutical, and combination product fields. In addition to his current role as a Regulatory Affairs Specialist, he also helps small MedTech companies stay compliant with AI-powered, human-driven internal audits and publishes the QA/RA Playbook, a free weekly newsletter helping subscribers simplify compliance, empower innovation, and advance their careers.  

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. 

Link

Darrin Carlson LinkedIn:  https://www.linkedin.com/in/darrinlcarlson/ 

Fix the Top 6 QMS Issues: https://qarasolutions.com/fixthetopsix 

FDA page on Warning Letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters 

FDA page on 483 data: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations 

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 hosted by Podcastics, the easiest platform to create and publish your podcast.

Sponsor

Medboard: https://www.medboard.com/

Europe

Health Data Legislation - Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500327&qid=1741166600030

FAQ: https://health.ec.europa.eu/document/download/4dd47ec2-71dd-49fc-b036-ad7c14f6ed68_en?filename=ehealth_ehds_qa_en.pdf

eIFU proposal until March 21st- eIFU for professional user:  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14470-Medical-devices-electronic-instructions-for-use_en

14th Notified Body Under IVDR - Centro Nacional de Certification de Productos Sanitarios: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43640&filter=notificationStatusId:1

Exceptional access of Non-CE Medical Devices - France simplified form: https://ansm.sante.fr/actualites/acces-derogatoire-pour-un-dispositif-medical-depourvu-de-marquage-ce-optimisation-du-processus-de-demande-a-lansm

EMA scientific Advice for High-risk device - Portal available: https://www.ema.europa.eu/en/news/ema-establishes-regular-procedure-scientific-advice-certain-high-risk-medical-devices

Guide: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf

IGJ on Generative AI in Healthcare - Be careful: https://www.igj.nl/zorgsectoren/medische-technologie/publicaties/publicaties/2025/02/10/igj-roept-zorgaanbieders-op-ga-zorgvuldig-om-met-invoering-van-generatieve-ai-toepassingen

Pilot for Clinical Investigation and Performance Study - 1 application for all member states: https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en

FAQ: https://health.ec.europa.eu/document/download/7ee00635-08dd-4c24-b892-74fc8eebfb54_en?filename=md_ci_pilot-ci-ps_faq_0.pdf

Participating member states: https://health.ec.europa.eu/document/download/e987dcf9-cc8c-44c4-b772-18919cd3f84c_en?filename=md_ci_pilot-ci-ps_ms-pilot-coordinated-assessment.pdf

What is an AI system - Read the guide: https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application

Switzerland

Swissmedic assessment on PMS - Result is BAD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/ueberpruefung-dokumentation-ueberwachung-nach-inverkehrbringen-smc.html

UK

IVD registration in the UK - Transition to IVDR: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

EU IVDD Extension:  https://www.gov.uk/government/publications/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates/registration-of-certain-in-vitro-diagnostic-devices

Reliance on Exention of CE- Reusable Class I devices : https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif#reliance-on-extended-certificates-in-great-britain-gb-

Webinar

28 March - AI in Healthcare - EU priorities and Ecosystem Synergies: https://digital-strategy.ec.europa.eu/en/events/ai-healthcare-eu-priorities-and-ecosystem-synergies

Newsletter

Easy Medical Device Newsletter - Get fresh information: https://www.linkedin.com/posts/easymedicaldevice_medicaldevices-mdr-regulatorycompliance-activity-7304455925044531200-mKt0?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI

Medtech Leading Voice Newsletter -  Reference a lot of Medical Device posts: https://www.linkedin.com/newsletters/medtech-leading-voice-6871913764770324480/

ROW

Australia: Ask consent if product not compliant - Not compliant to the Essential Principles: https://www.tga.gov.au/resources/resource/reference-material/consent-medical-devices-do-not-meet-essential-principles

South Africa: Classification rules - Some rules were updated: https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf

Application to Canada - Draft guidance: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses/draft-guidance-on-managing-applications-for-medical-device-licences-eng.pdf

Podcast

Episode 323 - The good, the bad and the ugly of certification bodies with Mark Rogovoi; https://podcast.easymedicaldevice.com/323-2/

Episode 324 - How and who to build your Risk Management File with Bijan Elahi: https://podcast.easymedicaldevice.com/324-2/

Episode 325 - FDA: Advantage of the Breakthrough Device Program with Michelle Lott: https://podcast.easymedicaldevice.com/325-2/

Episode 326 - How to avoid Clinical Investigation for your Device with Hatem Rabeh: https://podcast.easymedicaldevice.com/326-2/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let’s clarify all this and give you the right strategies for your Medical Devices. So stay tuned. 

Who is Hatem Rabeh? 

Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.  

With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems.  His expertise covers literature reviews, clinical strategy, and regulatory compliance.  

Hatem also shares his knowledge through online training, consulting, and LinkedIn content. 

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. 

Link

Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/ 

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 hosted by Podcastics, the easiest platform to create and publish your podcast.

In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project. On some of my consulting projects, I ask people if they can send me their Risk Management File, which usually follows by “I don’t have one” and then by “How can we create one?”. So Today Bijan Elahi who is an expert on risk management will explain the best way to start such project. 

Who is Bijan Elahi? 

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and an affiliate professor at Drexel University. Previously he served as the Medtronic corporate Advisor on safety risk management of medical devices. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA). 

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling medical book: Safety Risk Management for Medical Devices, published by Elsevier publishing. 

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. 

Link

Linkedin Page: https://www.linkedin.com/in/bijanelahi/ 

Medtech Safety website: https://www.medtechsafety.com/

Safety Risk Management for Medical Devices Book: https://www.amazon.com/Safety-Risk-Management-Medical-Devices-ebook/dp/B09M3QXNL9/ref 

Conference website: https://medsafetyconf.net/home.php 

Conference registration page (early bird discounts end on 28 February): https://medsafetyconf.net/registreren.php 

Bijan’s email: [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 hosted by Podcastics, the easiest platform to create and publish your podcast.

In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is not all good. 

Who is Mark Rogovoi? 

Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master's degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University. 

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. 

Link

Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/ 

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 hosted by Podcastics, the easiest platform to create and publish your podcast.

Medboard

EU

EU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a

EU IVDR transition periods - Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdfEUDAMED

EMDN: UPDATE or not to UPDATE - MDCG 2024-2 Rev 1 and 2021-12 Rev 1 :

https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf
MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf
MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf

Contact points of National Authorities - Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf

EU Battery 2023/1542 - Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214

Swiss Maintenance of Medical Devices - Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html

UK timeline for UKCA - Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf

UK Post-Market Surveillance - Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation

https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf

PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports

PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes

PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type

TUK Vigilance Reporting - Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents

FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history

Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation

Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history

Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses

Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems

UK guide for IVD - Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf

Training

EU MDR training - Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/

Rest of the World:

Laboaratory Developed Tests FAQ - Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests

How to apply your dossier in Australia - Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment

Malaysia guidance for HIV Self-test - Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file

Import Medical Device for Personnal Use in Malaysia - What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file

Alert by Philippines for Product registration - Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf

Saudi Arabia clearance of Medical Devices - For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf

China Medical Device Regulations Round-up 2024 - Cisema.com video: 2024 Round-Up of China Medical Device regulations

India update classification lists - List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI=

Podcast

Episode 318 - How to register a Medical Device in South Africa - Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/

Episode 319 - How to perform your PMS for a Drug-Device Combination - Joan D'Souza: https://podcast.easymedicaldevice.com/319-2/

Episode 320 - Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/

Episode 321 - 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic. 

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. 

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 hosted by Podcastics, the easiest platform to create and publish your podcast.