All episodes
Prepare your transition from Class I to Class Ir
SaMD international reach – What to consider?
Biological Evaluation: Top Big mistakes
Medical Device News: February 2023 Regulatory Update
How to do Post-Marketing Surveillance in the US (vs EU)?
How to evaluate Benefit-Risk Ratio for Medical Devices?
Breaking News: EU MDR Extension Proposal is out for consultation
How to improve the relationship between QA – RA and Marketing?
Medical Device News: January 2023 Regulatory Update
Grow your LinkedIn Profile with Karandeep Badwal
Is EU MDR extended? with Erik Vollebregt
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
Medical Device News – December 2022 Regulatory Update
How to choose the best Sterilization Method for Medical Devices?
Why Risk Management is important to Medical Device development?
Regulatory Pathway: How to reach the US market? [510k exempt]
Your Software/IVD clinical report is completely WRONG!
Medical Device News – November 2022 Regulatory Update
Can you go to Jail as a PRRC? [Elem Ayne]
How to be MDSAP certified for your Medical Devices?
What do Clients, Followers, Team, … think of Easy Medical Device?
How to select your Notified Body and understand the full process?
How to become the best PRRC ever? [Ronald Boumans]
Why do you need an Initial Importer for the US Market?
Medical Device News: September 2022 Regulatory Update
SaMD or SiMD – How to create your Design Dossier?
New Blue Guide – What is the impact on Medical Devices?
Why are we not Discontinuing your Products?
When you think “510k” but FDA says “DeNovo” with Spencer Jones
How to create your Technical Documentation? [EU MDR and IVDR]
Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
Medical Device News – July 2022 Regulatory Update
Attention! 1 year before UKCA is the law for Medical Devices in the UK
Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
What are some Quality Common Mistakes? [Karandeep Badwal]
Medical Device News: June 2022 Regulatory Update
Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea
What to learn about the EU Medical Device situation? [Erik Vollebregt]
What happens after the IVDR Date of Application with Colm O’Rourke
How to certify your Software as a Medical Device? (SaMD)
Medical Device News: May 2022 Regulatory Update
Training Process – What are the mistakes to avoid? [ISO 13485]
How your PMCF is evaluated by your Notified Body? [Matthias Fink]
How to prepare an Audit with a Front Room & a Back Room?
Medical Device News: April 2022 Update
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
How to sell Medical Devices online in the EU and US?
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
Why do we need the Common Specification for Class D IVDR?
Medical Device News – March 2022 Regulatory Update
Why would you need a Swiss Authorised Representative and Importer?
How to be great at Management Reviews? [ISO 13485]
Why Design History File (DHF) is so important? [Alexandros Savvidis]
Medical Device News: February 2022 Regulatory Update
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
How to interview your QA RA Candidates? [Mitch Robbins]
How to accelerate your Laboratory Test Results? [Christoph Lindner]
Medical Device News – January 2022 [Happy New Year]
What happened in 2021? Summary for the Medical Device Industry
The Step-by-Step recipe to get MDR & IVDR Certified
Which devices cannot be Custom-made? [Erik Vollebregt]
Medical Device News: December 2021 Regulatory Update
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
Is it possible to Private Label a Medical Device under MDR & IVDR?
How to improve your QA RA Communication with Lesley Worthington?
Medical Device News – November 2021 latest update
How does the EU Commission plan to save IVDR 2017/746?
How to comply with MDR when products contain CMR Substances?
EUDAMED Update: Should you register your medical devices now?
Medical Device News – October 2021 Regulatory Update
Why does an Importer/Distributor need to appoint a Notified Body?
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
How to manage the IVDR transition period? [IVDR 2017/745]
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
Medical Device News – September 2021 Latest Updates
Medical Device News – August 2021 Regulatory Update [MDR & IVDR]
How to find a QA RA job for Medical Devices? [Karandeep Badwal]
What is the QA RA Mindset with Michelle Lott
February 2021 Update – Medical Devices Remote Audit by the EU
How to get the MDR certification for Artificial Intelligence Softwares?
How to register a Medical Device in Israel? (Liat Nadel)
How Easy Medical Device can help you? (Monir El Azzouzi)
Medical Device News: What happened in November 2020?
Is it Easy for a Notified Body to get EU MDR accredited?
Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
We’ve reached episode 100 – What happened for the last 2 years?