Medical Device made Easy Podcast
By easymedicaldevice
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Subscribers: 26
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Episodes: 294
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.
| Episode | Date |
|---|---|
|
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]
|
Mar 02, 2021 |
|
The best design methods for successful development? [Jon Speer]
|
Feb 23, 2021 |
|
How to find a QA RA job for Medical Devices? [Karandeep Badwal]
|
Feb 16, 2021 |
|
What is the QA RA Mindset with Michelle Lott
|
Feb 09, 2021 |
|
February 2021 Update – Medical Devices Remote Audit by the EU
|
Feb 02, 2021 |
|
How to perform your PMS more easily with Ivan Perez Chamorro?
|
Jan 26, 2021 |
|
How to get the MDR certification for Artificial Intelligence Softwares?
|
Jan 19, 2021 |
|
How to register a Medical Device in Israel? (Liat Nadel)
|
Jan 12, 2021 |
|
Medical Device News – January 2021 Update (Monir El Azzouzi)
|
Jan 05, 2021 |
|
How Easy Medical Device can help you? (Monir El Azzouzi)
|
Dec 28, 2020 |
|
How to deal with Significant Changes within MDR & IVDR with Martin Witte
|
Dec 21, 2020 |
|
How to register a Medical Device in Mexico? [Josué Garza]
|
Dec 14, 2020 |
|
Medical Device News: What happened in November 2020?
|
Dec 07, 2020 |
|
Is it Easy for a Notified Body to get EU MDR accredited?
|
Nov 30, 2020 |
|
How a Quality & Regulatory training can help you? [Sofmedica]
|
Nov 23, 2020 |
|
Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
|
Nov 16, 2020 |
|
What are Common Specifications under EU MDR & IVDR?
|
Nov 09, 2020 |
|
We’ve reached episode 100 – What happened for the last 2 years?
|
Nov 02, 2020 |
|
How to certify a self-testing device under IVDR? [Erik Vollebregt]
|
Oct 26, 2020 |
|
What is the cost of EU MDR 2017/745? [Catherine Higginson]
|
Oct 19, 2020 |
|
How to register your Medical Device in the ASEAN region?
|
Oct 12, 2020 |
|
The latest news on Brexit, Swixit and EU MDR [Medical Device News]
|
Oct 05, 2020 |
|
How to register ATMP-Device combination products?
|
Sep 28, 2020 |
|
How to get some help from Medical Device Regulators with Cliff Bleustein
|
Sep 21, 2020 |
|
How can GDPR impact Medical Devices with Erik Vollebregt
|
Sep 14, 2020 |
|
Be successful at your MDR and IVDR audit with Martin Witte
|
Sep 07, 2020 |
|
Medical Device News – August 2020 Review (Monir El Azzouzi)
|
Aug 31, 2020 |
|
How to switch quickly to a Virtual Conference with TOPRA
|
Aug 24, 2020 |
|
Best practice for Device Testing with Michael Wetherington
|
Aug 17, 2020 |
|
Best overview of IEC 60601 for Medical Device electrical equipment
|
Aug 10, 2020 |
|
Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
|
Aug 03, 2020 |
|
Learn UDI code for Medical Devices with Sylvia Reingardt
|
Jul 27, 2020 |
|
Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
|
Jul 20, 2020 |
|
How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
|
Jul 13, 2020 |
|
Medical Device News – June 2020 Update
|
Jul 06, 2020 |
|
The secrets to being EU MDR certified with Shokoufeh Khodabandeh
|
Jun 29, 2020 |
|
How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
|
Jun 22, 2020 |
|
How to execute your Internal Audits? (Medical Device companies)
|
Jun 15, 2020 |
|
Medical Device News – May 2020 Review with Monir El Azzouzi
|
Jun 08, 2020 |
|
What means Sufficient Clinical Data with Bassil Akra (EU MDR)
|
Jun 01, 2020 |
|
What is the Notified Body situation? (Bassil Akra from TUV SUD)
|
May 25, 2020 |
|
How to get ISO 13485 certified? (Quality Management System)
|
May 18, 2020 |
|
How to get your Digital Health Application reimbursed in Germany? (DIGA)
|
May 11, 2020 |
|
Medical Device News – April 2020 Regulatory Update
|
May 04, 2020 |
|
How to calculate your sample size with Jon Bergsteinsson
|
Apr 27, 2020 |
|
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
|
Apr 20, 2020 |
|
Medical Device School – Why are Staff hiding problems to QA & RA?
|
Apr 15, 2020 |
|
MDR & Drug-Device Combination Products with Theresa Jeary
|
Apr 13, 2020 |
|
Medical Device News – March 2020 Review (EU MDR)
|
Apr 06, 2020 |
|
What is a Significant Change for your Medical Device? with Erik Vollebregt
|
Mar 30, 2020 |
|
All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
|
Mar 23, 2020 |
|
Cybersecurity for your Medical Devices with Erik Vollebregt
|
Mar 16, 2020 |
|
Medical Device Regulatory Update – February 2020
|
Mar 09, 2020 |
|
Do your Economic Operators need a Quality Management System?
|
Mar 04, 2020 |
|
Create your intended purpose with Cesare Magri (Medical Device)
|
Mar 02, 2020 |
|
Medical Device School: What should verify your Economic Operators?
|
Feb 26, 2020 |
|
Clinical Data for Low Risk Medical Devices with Robert van Boxtel
|
Feb 24, 2020 |
|
Medical Device School – Who controls your Economic Operators?
|
Feb 19, 2020 |
|
Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt
|
Feb 17, 2020 |
|
Medical Device School – Who are your Economic Operators?
|
Feb 12, 2020 |
|
Swixit or not Swixit? this is the question with Ronald Boumans
|
Feb 10, 2020 |
|
Medical Device School – Process Validation or Verification?
|
Feb 05, 2020 |
|
Episode 61 – Medical Device Regulatory Update: January 2020
|
Feb 03, 2020 |
|
How to register your Device in Brazil with Tania Aprigliano? (ANVISA)
|
Jan 27, 2020 |
|
Why is it Awesome to work in a Quality or Regulatory affairs job?
|
Jan 22, 2020 |
|
How to create a QMS compliant to MDR with Stefan Bolleininger
|
Jan 20, 2020 |
|
How to register your Medical Device through 510k with Michelle Lott
|
Jan 13, 2020 |
|
Medical Device School: How to audit your Suppliers?
|
Jan 08, 2020 |
|
Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
|
Jan 06, 2020 |
|
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 |
|
Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
|
Dec 09, 2019 |
|
How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen?
|
Dec 02, 2019 |
|
Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch
|
Nov 25, 2019 |
|
Medical Device School: Product Development or Documentation creation?
|
Nov 21, 2019 |
|
EUDAMED is delayed, so What? with Richard Houlihan
|
Nov 18, 2019 |
|
Literature Search for your CER with Ed Drower
|
Nov 11, 2019 |
|
Medical Device School: How to build a Gap Assessment Tool?
|
Nov 07, 2019 |
|
How to validate an eQMS with Jacob Sjorslev
|
Nov 04, 2019 |
|
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 |
|
Learn Post Market Surveillance with Natasha Bankowski
|
Sep 15, 2019 |
|
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 |
|
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 |
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Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
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Apr 15, 2019 |
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Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
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Apr 08, 2019 |
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Episode 17 – Unannounced audit stories with Florent Guyon
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Apr 01, 2019 |
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Episode 16 – From Disease to a Medical Device with Sean Hamilton
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Mar 25, 2019 |
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Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
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Mar 18, 2019 |
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Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
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Mar 11, 2019 |
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Episode 13 – Brexit Talk with Richard Young
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Mar 04, 2019 |
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Episode 12 – How to create an ISO Standard with Marcelo Antunes
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Feb 25, 2019 |
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Episode 11 – Medical Device Software Validation
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Feb 17, 2019 |
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Episode 10 – Understand MDSAP with Angelina Hakim
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Feb 11, 2019 |
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Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
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Feb 03, 2019 |
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Episode 8 – From Correction to Prevention with ODIAC
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Jan 27, 2019 |
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Episode 7 – Make your KPIs Green again
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Jan 20, 2019 |
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Episode 6 – What are the 6 types of Medical Device Audits
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Jan 12, 2019 |
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Episode 5 – Medtech Prediction 2019
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Jan 06, 2019 |
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Episode 4 – UDI for Unique Device Identification
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Dec 29, 2018 |
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Episode 3 – Is my Product a Medical Device in Europe?
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Dec 20, 2018 |
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Episode 2 – New EU Medical Device Regulation MDR 2017/745
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Dec 16, 2018 |
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Episode 1 – Introduction to the Medical Device made Easy Podcast
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Dec 14, 2018 |