In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification. 

Who is Carmen Bellebna? 

Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye’s QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment. 

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

Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ 

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode. 

Who is Cecile van der Heijden? 

Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU. 

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

Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/ 

Axon Lawyers website: https://www.axonlawyers.com/ 

EHDS: https://www.european-health-data-space.com/ 

Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/

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

Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we’ll let you know when and why you should involve them earlier. Listen to this episode. 

Who is Aouda Ouzzaa? 

Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD). 

Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations. 

As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges. 

Whether you're developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success. 

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

Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32 

SmartQARA website: https://smartqara.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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode.

Who is Claire Dyson?

Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS's application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS's international team developing accessible content to support manufacturers with the regulatory pathways and transitions.

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 from the Video

Claire Dyson LinkedIn:  Claire Dyson | LinkedIn 

Blogs – 3 part series on U vs UK PMS  

UK PMS Regulations: Overview & Key Requirements for Medical Device Safety 

UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements 

UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices 

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable. 

Who is Adam Isaacs Rae? 

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

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

Adam Isaacs Rae LinkedIn:   https://www.linkedin.com/in/adam-isaacs-rae/

https://theotherconsultants.substack.com/p/register-your-medical-device-in-malaysia

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

In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. You will see within this episode that this is not something made for everyone, so you really need to listen to this to understand if this is the right decision for you. 

Who is Yassine Bader? 

Coach expert en transition de carrière et leadership, Yassine Bader cumule plus de 15 ans d'expérience au cœur de l'industrie (automobile, chimique, dispositifs médicaux, transport, pharmaceutique et agroalimentaire), accompagnant avec succès plus de 100 cadres vers une indépendance entrepreneuriale inspirante et un leadership d’excellence. Son approche : pragmatique, percutante, tournée vers l’action et les résultats concrets. Créateur du guide gratuit et fondateur du programme ManagerImpact, il équipe les managers d'outils précis et immédiatement exploitables pour devenir des leaders alignés, confiants et reconnus. Très prochainement, il dévoilera un séminaire exclusif destiné aux cadres industriels décidés à franchir le pas vers le consulting et le management de transition freelance, en leur fournissant toutes les clés indispensables pour réussir avec confiance leur nouvelle vie professionnelle.

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

Yassine Bader LinkedIn: https://www.linkedin.com/in/yassine-bader-yab/

Programme Yassinebader: https://programme.yassinebader.com/manager-impact

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

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.

Specialties: Software Processes Management.

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

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

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

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