Medical Device made Easy Podcast
By easymedicaldevice
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Subscribers: 27
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Episodes: 407
Description
My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
| Episode | Date |
|---|---|
|
The Audit Readiness Myth: Why Most Startups Aren't As Prepared As They Think
|
Jul 23, 2026 |
|
The FDA Clearance Journey: What Nobody Tells Medical Device Startups
|
Jul 16, 2026 |
|
The Audit Went Perfectly... So Why Are We Still in Trouble?
|
Jul 09, 2026 |
|
Medical Device News July 2026 Regulatory Update
|
Jul 02, 2026 |
|
"We've Never Had a Complaint" — The Most Dangerous Sentence in Medical Devices
|
Jun 25, 2026 |
|
NC vs CAPA: Are You Opening the Wrong Records?
|
Jun 17, 2026 |
|
Best of „AI CE marking“
|
Jun 11, 2026 |
|
Medical Device News June 2026 Regulatory Update
|
Jun 03, 2026 |
|
FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
|
May 28, 2026 |
|
How can a proper Intended Use save your device?
|
May 21, 2026 |
|
Medical Device News May 2026 Regulatory Update
|
May 13, 2026 |
|
The Hidden Costs of UDI Mistakes in Medical Devices
|
May 07, 2026 |
|
Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand
|
Apr 30, 2026 |
|
Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
|
Apr 22, 2026 |
|
The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit
|
Apr 16, 2026 |
|
AI Medical Devices: What Notified Bodies Really Look For
|
Apr 08, 2026 |
|
Medical Device News APRIL 2026 Regulatory Update
|
Apr 01, 2026 |
|
These 3 podcasts will change how you see MedTech
|
Mar 26, 2026 |
|
EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
|
Mar 19, 2026 |
|
Medical Device News March 2026 Regulatory Update
|
Mar 13, 2026 |
|
IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
|
Mar 05, 2026 |
|
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
|
Feb 26, 2026 |
|
Defect Management in SaMD — From Chaos to Control
|
Feb 19, 2026 |
|
Medical Device News February 2026 Regulatory Update
|
Feb 11, 2026 |
|
Validation & Supplier Management in MedTech
|
Feb 05, 2026 |
|
QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026
|
Jan 28, 2026 |
|
How to Remediate a Design History File (DHF)
|
Jan 22, 2026 |
|
Medical Device News January 2026 Regulatory Update
|
Jan 15, 2026 |
|
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
|
Jan 07, 2026 |
|
Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next
|
Dec 31, 2025 |
|
Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
|
Dec 24, 2025 |
|
From Engineer to Clinical Evaluation Expert - The Journey of Florian Tolkmitt
|
Dec 17, 2025 |
|
Medical Device News DECEMBER 2025 Regulatory Update
|
Dec 11, 2025 |
|
How to become a LEAD AUDITOR made Easy
|
Dec 04, 2025 |
|
What is changing with the new ISO 10993-1 version 2025
|
Nov 27, 2025 |
|
From Zero to One: The journey of a CRO with Helene Quie
|
Nov 20, 2025 |
|
Medical Device News November 2025 Regulatory Update
|
Nov 12, 2025 |
|
Automatisation of your QA RA job with AI
|
Nov 05, 2025 |
|
US Government Shutdown – What FDA can still be doing?
|
Oct 30, 2025 |
|
Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
|
Oct 23, 2025 |
|
Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
|
Oct 16, 2025 |
|
Highlights from La Rentrée du DM 2025
|
Oct 09, 2025 |
|
Medical Device News OCTOBER 2025 Regulatory Update
|
Oct 01, 2025 |
|
Post-Market Surveillance for Software and AI Devices
|
Sep 24, 2025 |
|
From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey
|
Sep 18, 2025 |
|
Cybersecurity in Medical Devices – What QA/RA Must Do Today
|
Sep 10, 2025 |
|
Medical Device News September 2025 Regulatory Update
|
Sep 04, 2025 |
|
The good, bad and uglyof using AIfor QA RA Compliance
|
Aug 28, 2025 |
|
Medical Device Software Versioning
|
Aug 21, 2025 |
|
From Zero to One How to collaborate with clients
|
Aug 14, 2025 |
|
From Zero to One: Becoming a Medical Device auditor
|
Aug 08, 2025 |
|
From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode
|
Jul 31, 2025 |
|
Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers
|
Jul 24, 2025 |
|
Quality & Regulatory in MedTech – Interview with Pardeep Kaur
|
Jul 17, 2025 |
|
From Zero to One: Creating your Consulting Firm
|
Jul 10, 2025 |
|
Medical Device News JULY 2025 Regulatory Update
|
Jul 03, 2025 |
|
From Zero to One: SaaS Founder's First Five Years
|
Jun 25, 2025 |
|
Notified Bodies raise concern on Risk Grading
|
Jun 18, 2025 |
|
Software as a Medical Device: Beginner’s Guide to Testing & Validation
|
Jun 12, 2025 |
|
Medical Device News JUNE 2025 Regulatory Update
|
Jun 04, 2025 |
|
Trapped or Strategic? Changing Notified Bodies During MDR Transition
|
May 29, 2025 |
|
How deepeye Medical overcame the AI ACT?
|
May 22, 2025 |
|
Is EHDS dangerous for Medical Device manufacturers?
|
May 15, 2025 |
|
When is Regulatory Affairs needed during Design?
|
May 07, 2025 |
|
What is the new UK Post-Market Surveillance Requirements?
|
May 01, 2025 |
|
How to register your Medical Device in Malaysia?
|
Apr 24, 2025 |
|
Should you quit your job to become a consultant?
|
Apr 17, 2025 |
|
How to satisfy Cybersecurity for FDA and EU?
|
Apr 10, 2025 |
|
Medical Device News April 2025 Regulatory Update
|
Apr 04, 2025 |
|
What if the Notified Body asks you: Is your Software Validated?
|
Mar 27, 2025 |
|
What are the TOP 3 FDA inspection issues?
|
Mar 20, 2025 |
|
Medical Device News March 2025 Regulatory Update
|
Mar 13, 2025 |
|
How to avoid Clinical Investigation for your Device?
|
Mar 06, 2025 |
|
How and Who to build your Risk Management File?
|
Feb 20, 2025 |
|
The good, the bad and the ugly of certification bodies
|
Feb 13, 2025 |
|
Medical Device News January 2025 Regulatory Update
|
Feb 06, 2025 |
|
6 Tips to Grow as a QA RA Manager
|
Jan 30, 2025 |
|
TOP 5 common NCs on an ISO 13485 audit
|
Jan 23, 2025 |
|
How to perform your PMS for a Drug-Device Combination?
|
Jan 16, 2025 |
|
How to register a Medical Device in South Africa?
|
Jan 09, 2025 |
|
Medica: AI & MDR FLIP THE COIN
|
Jan 02, 2025 |
|
Easy Medical Device Great Summary 2024
|
Dec 26, 2024 |
|
What are the major pitfalls of Startups in Medical Devices?
|
Dec 19, 2024 |
|
Medical Device News december 2024 Regulatory Update
|
Dec 12, 2024 |
|
PCCP – The Magic tool for SaMD in the US?
|
Dec 05, 2024 |
|
IEC 60601-1-8 How to test your Medical Device alarms?
|
Nov 28, 2024 |
|
How to build the perfect Quality Management System?
|
Nov 21, 2024 |
|
Is FMEA bad for your Risk Management?
|
Nov 14, 2024 |
|
How MDR and IVDR code can save you money?
|
Nov 07, 2024 |
|
Medical Device News November 2024 Regulatory Update
|
Oct 31, 2024 |
|
What does a strategy for regulatory compliance looks like?
|
Oct 24, 2024 |
|
What are the TOP 3 issues on CAPAs?
|
Oct 17, 2024 |
|
Medical Device News, october 2024 Regulatory Update
|
Oct 10, 2024 |
|
How to select the best plastic for your Medical Device?
|
Oct 03, 2024 |
|
UK vs EU vs US – How to switch to another region easily?
|
Sep 24, 2024 |
|
How to do a PMCF Literature Search for Medical Devices?
|
Sep 17, 2024 |
|
Medical Device News, Septembre 2024 Regulatory Update
|
Sep 10, 2024 |
|
How to use AI GPT for your Quality and Regulatory work?
|
Sep 05, 2024 |
|
How to go from Zero to Hero in Medical Devices?
|
Aug 27, 2024 |
|
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate
|
Aug 20, 2024 |
|
How to use Harmonized Standards for Medical Devices?
|
Aug 14, 2024 |
|
IVDR Class D – Lesson learned from Notified Bodies
|
Aug 06, 2024 |
|
EU MDR Major update: Interruption or Discontinuation of supply!
|
Jul 30, 2024 |
|
How to register your Medical Device in the UAE?
|
Jul 23, 2024 |
|
EU Battery Regulation – How to be ready?
|
Jul 16, 2024 |
|
AI Act – What are the challenges for Medical Devices?
|
Jul 09, 2024 |
|
Medical Device News, July 2024 Regulatory Update
|
Jul 05, 2024 |
|
How to submit your AI/ML SAMD the right way?
|
Jun 25, 2024 |
|
AFNOR - How is a Notified Body designated?
|
Jun 18, 2024 |
|
Cleaning Validation – How to select the worst case?
|
Jun 11, 2024 |
|
Medical Device News June 2024 Regulatory Update
|
Jun 06, 2024 |
|
Summative Evaluation – Common mistakes
|
May 27, 2024 |
|
Are you more Corrections or Corrective Actions or Preventive Actions?
|
May 21, 2024 |
|
How to select and evaluate your Contract Manufacturer?
|
May 13, 2024 |
|
Quality Field Service for Medical Devices?
|
May 07, 2024 |
|
Medical Device NewsMAY 2024 Regulatory Update
|
May 02, 2024 |
|
Why and how to build a Quality Culture?
|
Apr 23, 2024 |
|
What is the impact of AI Act on Medical Devices?
|
Apr 16, 2024 |
|
Radiation Sterilisation Master File (ISO 11137 & 11607)
|
Apr 09, 2024 |
|
Medical Device News April 2024 Regulatory Update
|
Apr 04, 2024 |
|
ow to benefit from Surveys to build Clinical Evidence?
|
Mar 26, 2024 |
|
How to do Postmarketing Surveillance the right way?
|
Mar 19, 2024 |
|
FDA aligns QMSR with ISO 13485?
|
Mar 12, 2024 |
|
Medical Device News March 2024 Regulatory Update
|
Mar 06, 2024 |
|
New EU Proposal - EUDAMED, IVDR & Shortage
|
Feb 27, 2024 |
|
Will EtO gaz become a Medical Device?
|
Feb 20, 2024 |
|
How to get your interview prepared?
|
Feb 13, 2024 |
|
Medical Device News february 2024 Regulatory Update
|
Feb 07, 2024 |
|
Why you should use Pre-Submission or Q-Sub with FDA?
|
Jan 30, 2024 |
|
You are not the Physical Manufacturer, can you be MDR certified?
|
Jan 23, 2024 |
|
MEDICA 2023 - InterviewS with Startups, Service Providers, Notified Bodies...
|
Jan 18, 2024 |
|
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!
|
Jan 16, 2024 |
|
Medical Device News – january 2024 Regulatory Update
|
Jan 10, 2024 |
|
Regulatory Maturity Model – Heatmap (MEDICA 2023)
|
Jan 02, 2024 |
|
Life of QA RA Podcasters?
|
Dec 26, 2023 |
|
Why should you invest in your Regulatory Team?
|
Dec 18, 2023 |
|
What is Usability for Medical Devices?
|
Dec 12, 2023 |
|
Medical Device News: December 2023 Regulatory Update
|
Dec 06, 2023 |
|
What is the situation regarding digitalization in Medtech?
|
Nov 28, 2023 |
|
How to find your Predicate Device for your 510K Submission?
|
Nov 21, 2023 |
|
How to CE certify a Calculator, Risk Score…?
|
Nov 14, 2023 |
|
Medical Device News – November 2023 Regulatory Update
|
Nov 09, 2023 |
|
Validate your Iphone, Samsung Galaxy, Huawei… for your Software
|
Oct 31, 2023 |
|
Afrisummit 2023 Interviews Part 2 – Egypt Situation
|
Oct 24, 2023 |
|
Afrisummit 2023 Interviews Part 1
|
Oct 17, 2023 |
|
What are some pitfalls to avoid during Software Design?
|
Oct 10, 2023 |
|
MEDICAL DEVICE NEWS October 2023 Regulatory Update
|
Oct 04, 2023 |
|
What is the EUDAMED Update?
|
Sep 26, 2023 |
|
Interviews on Being The PRRC
|
Sep 19, 2023 |
|
Interviews on Being The PRRC
|
Sep 13, 2023 |
|
MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update
|
Sep 06, 2023 |
|
How to perform your Cleaning Validation in practice?
|
Aug 29, 2023 |
|
What are the Acceptance Criteria for your Clinical Evaluation?
|
Aug 22, 2023 |
|
Why you should automate your Software validation?
|
Aug 15, 2023 |
|
Hire your QA RA person with no Budget
|
Aug 08, 2023 |
|
Who should be on your Risk Management Dream Team?
|
Aug 01, 2023 |
|
Artificial Intelligence in the Medical Device Industry
|
Jul 25, 2023 |
|
Validation of Quality Softwares in MedDev
|
Jul 18, 2023 |
|
How to register Medical Devices in Saudi Arabia
|
Jul 11, 2023 |
|
Medical Device News - July 2023 Regulatory Update
|
Jul 04, 2023 |
|
What should you know on UKCA extension
|
Jun 27, 2023 |
|
How to connect Software dev and QA RA Team
|
Jun 20, 2023 |
|
The great misunderstanding of EU MDR amendments
|
Jun 13, 2023 |
|
Medical Device News -June 2023 regulatory update
|
Jun 08, 2023 |
|
How to master regulatory intelligence
|
May 30, 2023 |
|
What if your Medical Device company goes Bankrupt?
|
May 23, 2023 |
|
Technical Files Inconsistencies identified by Notified Bodies
|
May 16, 2023 |
|
The truth about the UK vs EU situation
|
May 09, 2023 |
|
Medical Device news - May 2023 Regulatory Update
|
May 05, 2023 |
|
Transition to Agile for Software as Medical Device
|
Apr 25, 2023 |
|
Prepare your audit like a PRO
|
Apr 18, 2023 |
|
What is a SOUP for your Software Development
|
Apr 11, 2023 |
|
Medical Device news for April 2023
|
Apr 04, 2023 |
|
How to perform Risk Management for a Software ?
|
Mar 28, 2023 |
|
Proactive Postmarketing Surveillance. What does it mean?
|
Mar 21, 2023 |
|
What you should know about Vigilance Reporting?
|
Mar 14, 2023 |
|
Medical Device News: March 2023 Regulatory Update
|
Mar 08, 2023 |
|
Principal at Test labs
|
Feb 28, 2023 |
|
SaMD international reach – What to consider?
|
Feb 21, 2023 |
|
Biological Evaluation: Top Big mistakes
|
Feb 14, 2023 |
|
Medical Device News - February 2023 Regulatory Update
|
Feb 07, 2023 |
|
How to do Post-Marketing Surveillance in the US (vs EU)?
|
Jan 31, 2023 |
|
How to evaluate Benefit-Risk Ratio for Medical Devices?
|
Jan 24, 2023 |
|
Breaking News: EU MDR Extension Proposal is out for consultation
|
Jan 17, 2023 |
|
How to improve the relationship between QA – RA and Marketing?
|
Jan 10, 2023 |
|
Medical Device News: January 2023 Regulatory Update
|
Jan 03, 2023 |
|
Grow your LinkedIn Profile with Karandeep Badwal
|
Dec 27, 2022 |
|
EU MDR proposal for extension - Full story with Erik Vollebregt
|
Dec 20, 2022 |
|
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
|
Dec 13, 2022 |
|
Medical Device News - December 2022
|
Dec 06, 2022 |
|
How to choose the best Sterilisation Method for Medical Devices?
|
Nov 29, 2022 |
|
Why Risk Management is important to Medical Device development?
|
Nov 22, 2022 |
|
Regulatory Pathway: How to reach the US market [Class II 510k exempt]
|
Nov 15, 2022 |
|
Your Software/IVD clinical report is completely WRONG!
|
Nov 08, 2022 |
|
Medical Device News - November 2022 Regulatory Update
|
Nov 01, 2022 |
|
Can a PRRC go to Jail? [Elem Ayne]
|
Oct 25, 2022 |
|
How to be MDSAP certified for your Medical Device?
|
Oct 18, 2022 |
|
Medical Device News - October 2022 Regulatory Update
|
Oct 11, 2022 |
|
EPISODE 200 Celebration - Feedback from EMD Stakeholders
|
Oct 04, 2022 |
|
How to select your Notified Body and understand the full process?
|
Sep 27, 2022 |
|
How to become the best PRRC ever? [Ronald Boumans]
|
Sep 20, 2022 |
|
Why do you need an Initial Importer for the US Market?
|
Sep 13, 2022 |
|
Medical Device News - September 2022 Regulatory Update
|
Sep 06, 2022 |
|
SaMD or SiMD - How to create a Design Dossier?
|
Aug 30, 2022 |
|
The New Blue Guide - What is the impact to the Medical Device Industry?
|
Aug 23, 2022 |
|
Why don't you discontinue correctly your Medical Devices?
|
Aug 16, 2022 |
|
When you think “510k” but FDA says “DeNovo” with Spencer Jones
|
Aug 09, 2022 |
|
How to create a Technical Documentation? [EU MDR and IVDR]
|
Aug 02, 2022 |
|
Do you need a Cleanroom for your Medical Devices? [Philippe Bourbon]
|
Jul 26, 2022 |
|
AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
|
Jul 19, 2022 |
|
Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
|
Jul 12, 2022 |
|
Medical Device news - July 2022 Regulatory Update
|
Jul 05, 2022 |
|
Attention! 1 year before UKCA is the law for Medical Devices in the UK
|
Jun 28, 2022 |
|
Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
|
Jun 21, 2022 |
|
How to avoid these common mistakes on your Quality System? [Karandeep Badwal]
|
Jun 14, 2022 |
|
Medical Device News - June 2022 Regulatory Update
|
Jun 07, 2022 |
|
Let's introduce our eQMS Smarteye with Anindya Mookerjea
|
May 31, 2022 |
|
What is the EU Medical Device Situation? with Erik Vollebregt
|
May 24, 2022 |
|
What happens after the IVDR Date of Application with Colm O’Rourke
|
May 17, 2022 |
|
Certify your Software as a Medical Device with Vivek Thakkar
|
May 10, 2022 |
|
Medical Device News - May 2022 Regulatory Update
|
May 03, 2022 |
|
Training Procedure "How to avoid mistakes" with Rod Beuzeval and Katie Cooney
|
Apr 26, 2022 |
|
How your PMCF is evaluated by your Notified Body? [Matthias Fink]
|
Apr 19, 2022 |
|
Prepare your audit with a Front Room Back Room
|
Apr 12, 2022 |
|
Medical Device News: April 2022 Regulatory Update
|
Apr 05, 2022 |
|
What are some of the surprises during MDR and IVDR transition? [Erik Vollebregt]
|
Mar 29, 2022 |
|
How to sell Medical Devices on an Online Platform? [Michael Wetherington]
|
Mar 22, 2022 |
|
Which lessons did we learn doing Clinical Evaluations? [Cesare Magri]
|
Mar 15, 2022 |
|
IVDR Class D Common Specification with Andreas Stange [TÜV SÜD]
|
Mar 08, 2022 |
|
Medical Device News - March 2022 Regulatory Update
|
Mar 01, 2022 |
|
Why do you need a Swiss Authorised Representative and Importer?
|
Feb 22, 2022 |
|
How to have a great Management Review?
|
Feb 15, 2022 |
|
Why Design History File (DHF) is so important? [Alexandros Savvidis]
|
Feb 08, 2022 |
|
Medical Device News - February 2022 Regulatory Update
|
Feb 01, 2022 |
|
MDCG 2021-27 Placing on the market and Importer Re-labelling with Erik Vollebregt
|
Jan 25, 2022 |
|
How to interview QA RA candidates with Mitch Robbins
|
Jan 18, 2022 |
|
How to accelerate your Laboratory Test Results? [Christoph Lindner]
|
Jan 11, 2022 |
|
Medical Device News – January 2022 [Happy New Year]
|
Jan 04, 2022 |
|
What happened in 2021? Summary for the Medical Device Industry
|
Dec 28, 2021 |
|
The Step-by-Step recipe to get MDR & IVDR Certified
|
Dec 21, 2021 |
|
Which devices cannot be Custom-made? [Erik Vollebregt]
|
Dec 14, 2021 |
|
Medical Device News: December 2021 Regulatory Update
|
Dec 07, 2021 |
|
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
|
Nov 30, 2021 |
|
How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
|
Nov 23, 2021 |
|
Is it possible to Private Label a Medical Device under MDR & IVDR?
|
Nov 16, 2021 |
|
How to improve your QA RA Communication with Lesley Worthington?
|
Nov 09, 2021 |
|
Medical Device News – November 2021 latest update
|
Nov 02, 2021 |
|
How does the EU Commission plan to save IVDR 2017/746?
|
Oct 26, 2021 |
|
How to comply with MDR when products contain CMR Substances?
|
Oct 19, 2021 |
|
EUDAMED Update: Should you register your medical devices now?
|
Oct 12, 2021 |
|
Medical Device News – October 2021 Regulatory Update
|
Oct 05, 2021 |
|
Why does an Importer/Distributor need to appoint a Notified Body?
|
Sep 28, 2021 |
|
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
|
Sep 21, 2021 |
|
How to manage the IVDR transition period? [IVDR 2017/745]
|
Sep 14, 2021 |
|
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
|
Sep 07, 2021 |
|
Medical Device News – September 2021 Latest Updates
|
Aug 31, 2021 |
|
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
|
Aug 24, 2021 |
|
Better to be a Consultant or a Full-time employee? [Lifescience industry]
|
Aug 17, 2021 |
|
What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
|
Aug 10, 2021 |
|
Medical Device News – August 2021 Regulatory Update [MDR & IVDR]
|
Aug 03, 2021 |
|
How to implement Vigilance Reporting for MDR and IVDR?
|
Jul 27, 2021 |
|
System and Procedure Pack the RETURN with Erik Vollebregt
|
Jul 20, 2021 |
|
How to interpret the first Expert Panel Opinion? [Bassil Akra]
|
Jul 13, 2021 |
|
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
|
Jul 06, 2021 |
|
How to build your State-of-the-art for your Medical Devices?
|
Jun 29, 2021 |
|
How Intellectual Property is linked to the Medical Device Regulation?
|
Jun 22, 2021 |
|
How to perform a good Clinical Investigation with Helene Quie
|
Jun 15, 2021 |
|
How to perform a Biological Evaluation for your Medical Device?
|
Jun 08, 2021 |
|
Medical Device News – June 2021 Update [EU MDR Date of Application]
|
Jun 01, 2021 |
|
EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]
|
May 25, 2021 |
|
MDR is coming so brace yourself with Erik Vollebregt
|
May 18, 2021 |
|
FDA: Is the Emergency Use Authorization worth it? (EUA)
|
May 11, 2021 |
|
Medical Device News – May 2021 Update [EU MDR 2017/745]
|
May 04, 2021 |
|
Checklist – What is important before the EU MDR Date of Application?
|
Apr 27, 2021 |
|
How to perform correctly a Merger & Acquisition during the MDR transition?
|
Apr 20, 2021 |
|
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
|
Mar 30, 2021 |
|
How to create a Label under MDR? (Questions & Answers)
|
Mar 23, 2021 |
|
How System and Procedure Pack are regulated under EU MDR?
|
Mar 16, 2021 |
|
How to import your Medical Devices with an Independent Importer?
|
Mar 09, 2021 |
|
What is the Medical Device News? [March 2021 update]
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Mar 02, 2021 |
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The best design methods for successful development? [Jon Speer]
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Feb 23, 2021 |
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How to find a QA RA job for Medical Devices? [Karandeep Badwal]
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Feb 16, 2021 |
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What is the QA RA Mindset with Michelle Lott
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Feb 09, 2021 |
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February 2021 Update – Medical Devices Remote Audit by the EU
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Feb 02, 2021 |
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How to perform your PMS more easily with Ivan Perez Chamorro?
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Jan 26, 2021 |
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How to get the MDR certification for Artificial Intelligence Softwares?
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Jan 19, 2021 |
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How to register a Medical Device in Israel? (Liat Nadel)
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Jan 12, 2021 |
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Medical Device News – January 2021 Update (Monir El Azzouzi)
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Jan 05, 2021 |
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How Easy Medical Device can help you? (Monir El Azzouzi)
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Dec 28, 2020 |
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How to deal with Significant Changes within MDR & IVDR with Martin Witte
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Dec 21, 2020 |
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How to register a Medical Device in Mexico? [Josué Garza]
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Dec 14, 2020 |
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Medical Device News: What happened in November 2020?
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Dec 07, 2020 |
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Is it Easy for a Notified Body to get EU MDR accredited?
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Nov 30, 2020 |
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How a Quality & Regulatory training can help you? [Sofmedica]
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Nov 23, 2020 |
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Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
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Nov 16, 2020 |
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What are Common Specifications under EU MDR & IVDR?
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Nov 09, 2020 |
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We’ve reached episode 100 – What happened for the last 2 years?
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Nov 02, 2020 |
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How to certify a self-testing device under IVDR? [Erik Vollebregt]
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Oct 26, 2020 |
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What is the cost of EU MDR 2017/745? [Catherine Higginson]
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Oct 19, 2020 |
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How to register your Medical Device in the ASEAN region?
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Oct 12, 2020 |
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The latest news on Brexit, Swixit and EU MDR [Medical Device News]
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Oct 05, 2020 |
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How to register ATMP-Device combination products?
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Sep 28, 2020 |
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How to get some help from Medical Device Regulators with Cliff Bleustein
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Sep 21, 2020 |
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How can GDPR impact Medical Devices with Erik Vollebregt
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Sep 14, 2020 |
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Be successful at your MDR and IVDR audit with Martin Witte
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Sep 07, 2020 |
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Medical Device News – August 2020 Review (Monir El Azzouzi)
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Aug 31, 2020 |
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How to switch quickly to a Virtual Conference with TOPRA
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Aug 24, 2020 |
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Best practice for Device Testing with Michael Wetherington
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Aug 17, 2020 |
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Best overview of IEC 60601 for Medical Device electrical equipment
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Aug 10, 2020 |
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Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
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Aug 03, 2020 |
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Learn UDI code for Medical Devices with Sylvia Reingardt
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Jul 27, 2020 |
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Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
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Jul 20, 2020 |
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How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
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Jul 13, 2020 |
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Medical Device News – June 2020 Update
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Jul 06, 2020 |
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The secrets to being EU MDR certified with Shokoufeh Khodabandeh
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Jun 29, 2020 |
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How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
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Jun 22, 2020 |
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How to execute your Internal Audits? (Medical Device companies)
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Jun 15, 2020 |
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Medical Device News – May 2020 Review with Monir El Azzouzi
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Jun 08, 2020 |
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What means Sufficient Clinical Data with Bassil Akra (EU MDR)
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Jun 01, 2020 |
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What is the Notified Body situation? (Bassil Akra from TUV SUD)
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May 25, 2020 |
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How to get ISO 13485 certified? (Quality Management System)
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May 18, 2020 |
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How to get your Digital Health Application reimbursed in Germany? (DIGA)
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May 11, 2020 |
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Medical Device News – April 2020 Regulatory Update
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May 04, 2020 |
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How to calculate your sample size with Jon Bergsteinsson
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Apr 27, 2020 |
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The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
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Apr 20, 2020 |
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Medical Device School – Why are Staff hiding problems to QA & RA?
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Apr 15, 2020 |
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MDR & Drug-Device Combination Products with Theresa Jeary
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Apr 13, 2020 |
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Medical Device News – March 2020 Review (EU MDR)
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Apr 06, 2020 |
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What is a Significant Change for your Medical Device? with Erik Vollebregt
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Mar 30, 2020 |
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All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
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Mar 23, 2020 |
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Cybersecurity for your Medical Devices with Erik Vollebregt
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Mar 16, 2020 |
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Medical Device Regulatory Update – February 2020
|
Mar 09, 2020 |
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Do your Economic Operators need a Quality Management System?
|
Mar 04, 2020 |
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Create your intended purpose with Cesare Magri (Medical Device)
|
Mar 02, 2020 |
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Medical Device School: What should verify your Economic Operators?
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Feb 26, 2020 |
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Clinical Data for Low Risk Medical Devices with Robert van Boxtel
|
Feb 24, 2020 |
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Medical Device School – Who controls your Economic Operators?
|
Feb 19, 2020 |
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Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt
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Feb 17, 2020 |
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Medical Device School – Who are your Economic Operators?
|
Feb 12, 2020 |
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Swixit or not Swixit? this is the question with Ronald Boumans
|
Feb 10, 2020 |
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Medical Device School – Process Validation or Verification?
|
Feb 05, 2020 |
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Episode 61 – Medical Device Regulatory Update: January 2020
|
Feb 03, 2020 |
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How to register your Device in Brazil with Tania Aprigliano? (ANVISA)
|
Jan 27, 2020 |
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Why is it Awesome to work in a Quality or Regulatory affairs job?
|
Jan 22, 2020 |
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How to create a QMS compliant to MDR with Stefan Bolleininger
|
Jan 20, 2020 |
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How to register your Medical Device through 510k with Michelle Lott
|
Jan 13, 2020 |
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Medical Device School: How to audit your Suppliers?
|
Jan 08, 2020 |
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Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
|
Jan 06, 2020 |
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I wish you a Happy New Year 2020 with Monir El Azzouzi
|
Dec 30, 2019 |
|
6 ways to collect Clinical Data with David Rutledge
|
Dec 23, 2019 |
|
Class I Medical Devices under MDR with Erik Vollebregt (PART 2)
|
Dec 16, 2019 |
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Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
|
Dec 09, 2019 |
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How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen?
|
Dec 02, 2019 |
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Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch
|
Nov 25, 2019 |
|
Medical Device School: Product Development or Documentation creation?
|
Nov 21, 2019 |
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EUDAMED is delayed, so What? with Richard Houlihan
|
Nov 18, 2019 |
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Literature Search for your CER with Ed Drower
|
Nov 11, 2019 |
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Medical Device School: How to build a Gap Assessment Tool?
|
Nov 07, 2019 |
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How to validate an eQMS with Jacob Sjorslev
|
Nov 04, 2019 |
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How to implement an eQMS with Jacob Sjorslev
|
Oct 28, 2019 |
|
Medical Device School – Most important issues on your CAPA (ISO 13485)
|
Oct 24, 2019 |
|
Medical Device Disruptions at Hospitals with Stefan Krojer
|
Oct 20, 2019 |
|
5 FDA Myths for Start-Ups with Justin Bushko
|
Oct 14, 2019 |
|
GDPR & MDR for Medical Applications with Jovan Stevovic
|
Oct 06, 2019 |
|
Register your Medical Device in the US with Michelle Lott (FDA)
|
Sep 29, 2019 |
|
New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo
|
Sep 21, 2019 |
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Learn Post Market Surveillance with Natasha Bankowski
|
Sep 15, 2019 |
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Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie
|
Sep 07, 2019 |
|
Episode 39 – Networking at Medical Device events with Lynda Wight
|
Sep 01, 2019 |
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Episode 38 – Be the Best Candidate Ever with Mitch Robbins
|
Aug 26, 2019 |
|
Episode 37 – Usability & Human Factor with Sharon Ayd
|
Aug 19, 2019 |
|
Episode 36 – How to choose your PRRC with Erik Vollebregt
|
Aug 12, 2019 |
|
Episode 35 – Digitalization of QA RA with Michael Kania
|
Aug 05, 2019 |
|
Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
|
Jul 29, 2019 |
|
Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt
|
Jul 22, 2019 |
|
Episode 32 – Pakistan Registration Process with Muhammad Sohail
|
Jul 14, 2019 |
|
Episode 31 – First Regulatory Affairs Job with Karandeep Badwal
|
Jul 06, 2019 |
|
Episode 30 – Promotional Compliance with Darshan Kulkarni
|
Jun 30, 2019 |
|
Episode 29 – 5 Steps to create a QMS with Jason Lim
|
Jun 23, 2019 |
|
Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
|
Jun 16, 2019 |
|
Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
|
Jun 10, 2019 |
|
Episode 26 – IVDR preparation with Andreas Stange
|
Jun 03, 2019 |
|
Episode 25 – EUDAMED secrets with Richard Houlihan
|
May 27, 2019 |
|
Episode 24 – Myths about consultants with Thomas McMann
|
May 20, 2019 |
|
Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland
|
May 13, 2019 |
|
Episode 22 – Clinical Trial with Alethea Wieland
|
May 06, 2019 |
|
Episode 21 – How to master Regulatory Affairs with Samantha Alsbury
|
Apr 29, 2019 |
|
Episode 20 – What is a Blockchain with Khuram Malik
|
Apr 22, 2019 |
|
Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
|
Apr 15, 2019 |
|
Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
|
Apr 08, 2019 |
|
Episode 17 – Unannounced audit stories with Florent Guyon
|
Apr 01, 2019 |
|
Episode 16 – From Disease to a Medical Device with Sean Hamilton
|
Mar 25, 2019 |
|
Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
|
Mar 18, 2019 |
|
Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
|
Mar 11, 2019 |
|
Episode 13 – Brexit Talk with Richard Young
|
Mar 04, 2019 |
|
Episode 12 – How to create an ISO Standard with Marcelo Antunes
|
Feb 25, 2019 |
|
Episode 11 – Medical Device Software Validation
|
Feb 17, 2019 |
|
Episode 10 – Understand MDSAP with Angelina Hakim
|
Feb 11, 2019 |
|
Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
|
Feb 03, 2019 |
|
Episode 8 – From Correction to Prevention with ODIAC
|
Jan 27, 2019 |
|
Episode 7 – Make your KPIs Green again
|
Jan 20, 2019 |
|
Episode 6 – What are the 6 types of Medical Device Audits
|
Jan 12, 2019 |
|
Episode 5 – Medtech Prediction 2019
|
Jan 06, 2019 |
|
Episode 4 – UDI for Unique Device Identification
|
Dec 29, 2018 |
|
Episode 3 – Is my Product a Medical Device in Europe?
|
Dec 20, 2018 |
|
Episode 2 – New EU Medical Device Regulation MDR 2017/745
|
Dec 16, 2018 |
|
Episode 1 – Introduction to the Medical Device made Easy Podcast
|
Dec 14, 2018 |