Shows / Medical Device made Easy Podcast
Episodes
- Medical Device made Easy Podcast
Medical Device News September 2025 Regulatory Update
Medboard EUROPE Guidance on the implementation of the Master UDI-DI – MDCG 2024-14 – rev.1 …
- Medical Device made Easy Podcast
The good, bad and uglyof using AIfor QA RA Compliance
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…
- Medical Device made Easy Podcast
Medical Device Software Versioning
Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks—they…
- Medical Device made Easy Podcast
From Zero to One How to collaborate with clients
From Zero to One: Mastering Client Collaboration in Consulting Starting your consulting journey can feel overwhelming—finding clients, building trust, and…
- Medical Device made Easy Podcast
From Zero to One: Becoming a Medical Device auditor
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 Easy…
- Medical Device made Easy Podcast
From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode
In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs…
- Medical Device made Easy Podcast
Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory update—EU…
- Medical Device made Easy Podcast
Quality & Regulatory in MedTech – Interview with Pardeep Kaur
Quality & Regulatory in MedTech – Interview with Pardeep Kaur Background: From IT in India to MedTech in Norway You have a pretty fascinating background – you…
- Medical Device made Easy Podcast
From Zero to One: Creating your Consulting Firm
Guest: Stefan Bolleininger Title: From Zero to One: Creating your Consulting Firm Logo: Be on Quality Telling the story behind Be on Quality, the challenges…
- Medical Device made Easy Podcast
Medical Device News JULY 2025 Regulatory Update
Medboard: https://www.medboard.com/ EUROPE new eIFU rules – Let’s save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj…
- Medical Device made Easy Podcast
From Zero to One: SaaS Founder’s First Five Years
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 welcome Ivan…
- Medical Device made Easy Podcast
Notified Bodies raise concern on Risk Grading
Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does Risk Management mistakes that could cost you…
- Medical Device made Easy Podcast
Software as a Medical Device: Beginner’s Guide to Testing & Validation
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 essentials of…
- Medical Device made Easy Podcast
Medical Device News JUNE 2025 Regulatory Update
Europe Notified Body survey report – 31 October 2024 – What is the main Surprise…
- Medical Device made Easy Podcast
Trapped or Strategic? Changing Notified Bodies During MDR Transition
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…
- Medical Device made Easy Podcast
How deepeye Medical overcame the AI ACT?
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…
- Medical Device made Easy Podcast
Is EHDS dangerous for Medical Device manufacturers?
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…
- Medical Device made Easy Podcast
When is Regulatory Affairs needed during Design?
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…
- Medical Device made Easy Podcast
What is the new UK Post-Market Surveillance Requirements?
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…
- Medical Device made Easy Podcast
How to register your Medical Device in Malaysia?
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…
- Medical Device made Easy Podcast
Should you quit your job to become a consultant?
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…
- Medical Device made Easy Podcast
How to satisfy Cybersecurity for FDA and EU?
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…
- Medical Device made Easy Podcast
Medical Device News April 2025 Regulatory Update
Sponsor: Medboard Europe Certificates under Condition – Team NB press release…
- Medical Device made Easy Podcast
What if the Notified Body asks you: Is your Software Validated?
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…
- Medical Device made Easy Podcast
What are the TOP 3 FDA inspection issues?
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…
- Medical Device made Easy Podcast
Medical Device News March 2025 Regulatory Update
Sponsor Medboard: https://www.medboard.com/ Europe Health Data Legislation – Manufacturers should comply…
- Medical Device made Easy Podcast
How to avoid Clinical Investigation for your Device?
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…
- Medical Device made Easy Podcast
FDA: Advantage of the Breakthrough Device Program
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits?…
- Medical Device made Easy Podcast
How and Who to build your Risk Management File?
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…
- Medical Device made Easy Podcast
The good, the bad and the ugly of certification bodies
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…
- Medical Device made Easy Podcast
Medical Device News January 2025 Regulatory Update
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_1…
- Medical Device made Easy Podcast
6 Tips to Grow as a QA RA Manager
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…
- Medical Device made Easy Podcast
TOP 5 common NCs on an ISO 13485 audit
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 them he…
- Medical Device made Easy Podcast
How to perform your PMS for a Drug-Device Combination?
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…
- Medical Device made Easy Podcast
How to register a Medical Device in South Africa?
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 happen in…
- Medical Device made Easy Podcast
Medica: AI & MDR FLIP THE COIN
Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if you have any…
- Medical Device made Easy Podcast
Easy Medical Device Great Summary 2024
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…
- Medical Device made Easy Podcast
What are the major pitfalls of Startups in Medical Devices?
In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advice so you…
- Medical Device made Easy Podcast
Medical Device News December 2024 Regulatory Update
MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position – Making Medical Devices Safer and Faster…
- Medical Device made Easy Podcast
PCCP – The Magic tool for SaMD in the US?
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 regarding changes…
- Medical Device made Easy Podcast
IEC 60601-1-8 How to test your Medical Device alarms?
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 obvious…
- Medical Device made Easy Podcast
How to build the perfect Quality Management System?
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 QMS and…
- Medical Device made Easy Podcast
Is FMEA bad for your Risk Management?
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 and tell us…
- Medical Device made Easy Podcast
How MDR and IVDR code can save you money?
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 made Easy Podcast
Medical Device News November 2024 Regulatory Update
Medboard https://www.medboard.com/ EU Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf HMA…
- Medical Device made Easy Podcast
What does a strategy for regulatory compliance looks like?
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 provide…
- Medical Device made Easy Podcast
What are the TOP 3 issues on CAPAs?
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 System…
- Medical Device made Easy Podcast
Medical Device News, October 2024 Regulatory Update
Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5…
- Medical Device made Easy Podcast
How to select the best plastic for your Medical Device?
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 love to hear…
- Medical Device made Easy Podcast
UK vs EU vs US – How to switch to another region easily?
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 of EU…
- Medical Device made Easy Podcast
How to do a PMCF Literature Search for Medical Devices?
In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make…
- Medical Device made Easy Podcast
Medical Device News, Septembre 2024 Regulatory Update
EU e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN MDR…
- Medical Device made Easy Podcast
How to use AI GPT for your Quality and Regulatory work?
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 explain to…
- Medical Device made Easy Podcast
How to go from Zero to Hero in Medical Devices?
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 field to…
- Medical Device made Easy Podcast
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate
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’ll discuss…
- Medical Device made Easy Podcast
How to use Harmonized Standards for Medical Devices?
Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat…
- Medical Device made Easy Podcast
IVDR Class D – Lesson learned from Notified Bodies
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 class D…
- Medical Device made Easy Podcast
EU MDR Major update: Interruption or Discontinuation of supply!
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 integrated…
- Medical Device made Easy Podcast
How to register your Medical Device in the UAE?
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 Dubai is…
- Medical Device made Easy Podcast
EU Battery Regulation – How to be ready?
More and more regulations have to be applied parallel to the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon…