Medical Device made Easy Podcast
Episodes
Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand
30 Apr 2026
Contributed by Lukas
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.Now, Europe is i...
Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
22 Apr 2026
Contributed by Lukas
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is n...
The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit
16 Apr 2026
Contributed by Lukas
Many medical device companies believe they have a compliant Quality Management System (QMS).On paper, everything looks perfect:• Procedures are writ...
AI Medical Devices: What Notified Bodies Really Look For
08 Apr 2026
Contributed by Lukas
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized heal...
Medical Device News APRIL 2026 Regulatory Update
01 Apr 2026
Contributed by Lukas
MedboardSponsor: Medboard: https://www.medboard.com/ EUExtension of WET Class Iib - A new list with new products mentioned: https://eur-lex.europa....
These 3 podcasts will change how you see MedTech
26 Mar 2026
Contributed by Lukas
The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.To help you stay ahead, we’...
EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
19 Mar 2026
Contributed by Lukas
The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.While many companies be...
Medical Device News March 2026 Regulatory Update
13 Mar 2026
Contributed by Lukas
MedboardSponsor: Medboard: https://www.medboard.com/EuropePharmacist are distributors - French guide issued to educate them: https://medboard-public-a...
IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
05 Mar 2026
Contributed by Lukas
The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple co...
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
26 Feb 2026
Contributed by Lukas
IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based phi...
Defect Management in SaMD — From Chaos to Control
19 Feb 2026
Contributed by Lukas
In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impact...
Medical Device News February 2026 Regulatory Update
11 Feb 2026
Contributed by Lukas
SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards - Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-con...
Validation & Supplier Management in MedTech
05 Feb 2026
Contributed by Lukas
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episo...
QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026
28 Jan 2026
Contributed by Lukas
For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.But star...
How to Remediate a Design History File (DHF)
22 Jan 2026
Contributed by Lukas
Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during a...
Medical Device News January 2026 Regulatory Update
15 Jan 2026
Contributed by Lukas
Medboard: https://www.medboard.com/EuropeEMD Mag Issue 3 - For QA RA people: https://easymedicaldevice.com/emd-mag/EU to simplify MDR and IVDR - Propo...
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
07 Jan 2026
Contributed by Lukas
Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains on...
Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next
31 Dec 2025
Contributed by Lukas
As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key prioritie...
Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
24 Dec 2025
Contributed by Lukas
The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximatel...
From Engineer to Clinical Evaluation Expert - The Journey of Florian Tolkmitt
17 Dec 2025
Contributed by Lukas
Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in thi...
Medical Device News DECEMBER 2025 Regulatory Update
11 Dec 2025
Contributed by Lukas
MedboardEurope48% disruption in the EU - I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97f...
How to become a LEAD AUDITOR made Easy
04 Dec 2025
Contributed by Lukas
Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a ...
What is changing with the new ISO 10993-1 version 2025
27 Nov 2025
Contributed by Lukas
The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.Will we need to retest everything?Is this a...
From Zero to One: The journey of a CRO with Helene Quie
20 Nov 2025
Contributed by Lukas
In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulator...
Medical Device News November 2025 Regulatory Update
12 Nov 2025
Contributed by Lukas
MedBoard EUJoint clinical assessment procedure - EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TX...
Automatisation of your QA RA job with AI
05 Nov 2025
Contributed by Lukas
Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs.In this podcast episode, Hatem Rabeh joins to demystify how AI can be...
US Government Shutdown – What FDA can still be doing?
30 Oct 2025
Contributed by Lukas
US Government Shutdown – What the FDA Can Still Be Doing?When the U.S. government experiences a shutdown, the consequences ripple across every indus...
Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
23 Oct 2025
Contributed by Lukas
Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly.In thi...
Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
16 Oct 2025
Contributed by Lukas
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a maj...
Highlights from La Rentrée du DM 2025
09 Oct 2025
Contributed by Lukas
The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European a...
Medical Device News OCTOBER 2025 Regulatory Update
01 Oct 2025
Contributed by Lukas
MedboardEuropeTToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionP...
Post-Market Surveillance for Software and AI Devices
24 Sep 2025
Contributed by Lukas
Post-Market Surveillance for Software & AI Devices – A QA/RA GuideSoftware evolves with updates. AI models may even change with real-world data....
From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey
18 Sep 2025
Contributed by Lukas
From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical InnovationThe journey from a successful surgical career to the leadership of...
Cybersecurity in Medical Devices – What QA/RA Must Do Today
10 Sep 2025
Contributed by Lukas
bersecurity in Medical Devices – A QA/RA PerspectiveCybersecurity is often seen as an IT or engineering issue—but in reality, regulators and audit...
Medical Device News September 2025 Regulatory Update
04 Sep 2025
Contributed by Lukas
Medboard EUROPEGuidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-46...
The good, bad and uglyof using AIfor QA RA Compliance
28 Aug 2025
Contributed by Lukas
Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the...
Medical Device Software Versioning
21 Aug 2025
Contributed by Lukas
Managing Software Updates in Medical Devices: Best Practices & PitfallsIn the world of medical devices, software updates are never just technical ...
From Zero to One How to collaborate with clients
14 Aug 2025
Contributed by Lukas
From Zero to One: Mastering Client Collaboration in ConsultingStarting your consulting journey can feel overwhelming—finding clients, building trust...
From Zero to One: Becoming a Medical Device auditor
08 Aug 2025
Contributed by Lukas
Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made...
From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode
31 Jul 2025
Contributed by Lukas
In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Af...
Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
24 Jul 2025
Contributed by Lukas
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical DevicesOn July 16, 2025, a pivotal regulatory update—EU...
Quality & Regulatory in MedTech – Interview with Pardeep Kaur
17 Jul 2025
Contributed by Lukas
Background: From IT in India to MedTech in Norway You have a pretty fascinating background – you studied computer applications/IT back in India a...
From Zero to One: Creating your Consulting Firm
10 Jul 2025
Contributed by Lukas
Guest: Stefan Bolleininger Title: From Zero to One: Creating your Consulting Firm Logo: Be on Quality Telling the story behind Be on Quality, ...
Medical Device News JULY 2025 Regulatory Update
03 Jul 2025
Contributed by Lukas
Medboard: https://www.medboard.com/EUROPEnew eIFU rules - Let's save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/ojhttps://heal...
From Zero to One: SaaS Founder's First Five Years
25 Jun 2025
Contributed by Lukas
From Zero to One: SaaS Founder's First Five Years with Ivan Perez Chamorro 🎧💡In this exciting episode of the Easy Medical Device Podcast, we wel...
Notified Bodies raise concern on Risk Grading
18 Jun 2025
Contributed by Lukas
🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does🩺 Risk Management mist...
Software as a Medical Device: Beginner’s Guide to Testing & Validation
12 Jun 2025
Contributed by Lukas
■Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the e...
Medical Device News JUNE 2025 Regulatory Update
04 Jun 2025
Contributed by Lukas
EuropeNotified Body survey report - 31 October 2024 - What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f...
Trapped or Strategic? Changing Notified Bodies During MDR Transition
29 May 2025
Contributed by Lukas
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 ...
How deepeye Medical overcame the AI ACT?
22 May 2025
Contributed by Lukas
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...
Is EHDS dangerous for Medical Device manufacturers?
15 May 2025
Contributed by Lukas
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 M...
When is Regulatory Affairs needed during Design?
07 May 2025
Contributed by Lukas
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 u...
What is the new UK Post-Market Surveillance Requirements?
01 May 2025
Contributed by Lukas
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 ...
How to register your Medical Device in Malaysia?
24 Apr 2025
Contributed by Lukas
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 th...
Should you quit your job to become a consultant?
17 Apr 2025
Contributed by Lukas
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 withi...
How to satisfy Cybersecurity for FDA and EU?
10 Apr 2025
Contributed by Lukas
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...
Medical Device News April 2025 Regulatory Update
04 Apr 2025
Contributed by Lukas
Sponsor: MedboardEurope Certificates under Condition - Team NB press release: https://www.team-nb.org/wp-content/uploads/2025/03/PressRelease-WP3-Tas...
What if the Notified Body asks you: Is your Software Validated?
27 Mar 2025
Contributed by Lukas
https://www.pinterest.com/easymedicaldeviceIn this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if o...
What are the TOP 3 FDA inspection issues?
20 Mar 2025
Contributed by Lukas
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 wil...
Medical Device News March 2025 Regulatory Update
13 Mar 2025
Contributed by Lukas
SponsorMedboard: https://www.medboard.com/ EuropeHealth Data Legislation - Manufacturers should comply: https://eur-lex.europa.eu/legal-content/EN/TX...
How to avoid Clinical Investigation for your Device?
06 Mar 2025
Contributed by Lukas
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 a...
How and Who to build your Risk Management File?
20 Feb 2025
Contributed by Lukas
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 proj...
The good, the bad and the ugly of certification bodies
13 Feb 2025
Contributed by Lukas
In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturer...
Medical Device News January 2025 Regulatory Update
06 Feb 2025
Contributed by Lukas
MedboardEUEU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art...
6 Tips to Grow as a QA RA Manager
30 Jan 2025
Contributed by Lukas
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 ref...
TOP 5 common NCs on an ISO 13485 audit
23 Jan 2025
Contributed by Lukas
In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of t...
How to perform your PMS for a Drug-Device Combination?
16 Jan 2025
Contributed by Lukas
In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a...
How to register a Medical Device in South Africa?
09 Jan 2025
Contributed by Lukas
In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will ...
Medica: AI & MDR FLIP THE COIN
02 Jan 2025
Contributed by Lukas
Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if yo...
Easy Medical Device Great Summary 2024
26 Dec 2024
Contributed by Lukas
In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting...
What are the major pitfalls of Startups in Medical Devices?
19 Dec 2024
Contributed by Lukas
In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advi...
Medical Device News december 2024 Regulatory Update
12 Dec 2024
Contributed by Lukas
MEDBOARD: https://www.medboard.com/EUROPETEAM-NB high level position - Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/upl...
PCCP – The Magic tool for SaMD in the US?
05 Dec 2024
Contributed by Lukas
In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regardin...
IEC 60601-1-8 How to test your Medical Device alarms?
28 Nov 2024
Contributed by Lukas
In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so...
How to build the perfect Quality Management System?
21 Nov 2024
Contributed by Lukas
In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QM...
Is FMEA bad for your Risk Management?
14 Nov 2024
Contributed by Lukas
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this an...
How MDR and IVDR code can save you money?
07 Nov 2024
Contributed by Lukas
In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by...
Medical Device News November 2024 Regulatory Update
31 Oct 2024
Contributed by Lukas
Medboardhttps://www.medboard.com/EUUrgent update needed - EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdfHMA com...
What does a strategy for regulatory compliance looks like?
24 Oct 2024
Contributed by Lukas
In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t...
What are the TOP 3 issues on CAPAs?
17 Oct 2024
Contributed by Lukas
in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management ...
Medical Device News, october 2024 Regulatory Update
10 Oct 2024
Contributed by Lukas
Medboard: https://www.medboard.com/EUROPETEAM NB - Code of Conduct for NB - Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelea...
How to select the best plastic for your Medical Device?
03 Oct 2024
Contributed by Lukas
In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would lov...
UK vs EU vs US – How to switch to another region easily?
24 Sep 2024
Contributed by Lukas
In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example...
How to do a PMCF Literature Search for Medical Devices?
17 Sep 2024
Contributed by Lukas
In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people shou...
Medical Device News, Septembre 2024 Regulatory Update
10 Sep 2024
Contributed by Lukas
EUe-IFU for medical devices - Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=ENMDR Transit...
How to use AI GPT for your Quality and Regulatory work?
05 Sep 2024
Contributed by Lukas
In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will exp...
How to go from Zero to Hero in Medical Devices?
27 Aug 2024
Contributed by Lukas
In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the f...
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate
20 Aug 2024
Contributed by Lukas
In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’...
How to use Harmonized Standards for Medical Devices?
14 Aug 2024
Contributed by Lukas
Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion ...
IVDR Class D – Lesson learned from Notified Bodies
06 Aug 2024
Contributed by Lukas
The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th ...
EU MDR Major update: Interruption or Discontinuation of supply!
30 Jul 2024
Contributed by Lukas
The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be in...
How to register your Medical Device in the UAE?
23 Jul 2024
Contributed by Lukas
Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of D...
EU Battery Regulation – How to be ready?
16 Jul 2024
Contributed by Lukas
More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt f...
AI Act – What are the challenges for Medical Devices?
09 Jul 2024
Contributed by Lukas
I am an EU pharma/device lawyer and problem solver. My practice focuses on European Union (EU) and national regulatory matters involving medical devic...
Medical Device News, July 2024 Regulatory Update
05 Jul 2024
Contributed by Lukas
MedboardEUGermany warns against overregulation of Medical Devices - Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422Title...
How to submit your AI/ML SAMD the right way?
25 Jun 2024
Contributed by Lukas
You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important e...
AFNOR - How is a Notified Body designated?
18 Jun 2024
Contributed by Lukas
If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episod...
Cleaning Validation – How to select the worst case?
11 Jun 2024
Contributed by Lukas
Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a w...
Medical Device News June 2024 Regulatory Update
06 Jun 2024
Contributed by Lukas
EUROPEEU MDR 26 May 2024 - Was there any apocalypse:France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin...
Summative Evaluation – Common mistakes
27 May 2024
Contributed by Lukas
I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is I...