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Medical Device made Easy Podcast
Listen Medical Device Regulation and Standards
Medical Device News – May 2020 Review with Monir El Azzouzi
0 secs; June 07, 2020
What means Sufficient Clinical Data with Bassil Akra (EU MDR)
0 secs; May 31, 2020
What is the Notified Body situation? (Bassil Akra from TUV SUD)
0 secs; May 24, 2020
How to get ISO 13485 certified? (Quality Management System)
0 secs; May 17, 2020
How to get your Digital Health Application reimbursed in Germany? (DIGA)
0 secs; May 10, 2020
Medical Device News – April 2020 Regulatory Update
0 secs; May 03, 2020
How to calculate your sample size with Jon Bergsteinsson
0 secs; April 26, 2020
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
0 secs; April 19, 2020
Medical Device School – Why are Staff hiding problems to QA & RA?
0 secs; April 14, 2020
MDR & Drug-Device Combination Products with Theresa Jeary
0 secs; April 12, 2020
Medical Device News – March 2020 Review (EU MDR)
0 secs; April 05, 2020
What is a Significant Change for your Medical Device? with Erik Vollebregt
0 secs; March 29, 2020
All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
0 secs; March 22, 2020
Cybersecurity for your Medical Devices with Erik Vollebregt
0 secs; March 15, 2020
Medical Device Regulatory Update – February 2020
0 secs; March 08, 2020
Do your Economic Operators need a Quality Management System?
0 secs; March 03, 2020
Create your intended purpose with Cesare Magri (Medical Device)
0 secs; March 01, 2020
Medical Device School: What should verify your Economic Operators?
0 secs; February 25, 2020
Clinical Data for Low Risk Medical Devices with Robert van Boxtel
0 secs; February 23, 2020
Medical Device School – Who controls your Economic Operators?
0 secs; February 18, 2020
Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt
0 secs; February 16, 2020
Medical Device School – Who are your Economic Operators?
0 secs; February 11, 2020
Swixit or not Swixit? this is the question with Ronald Boumans
0 secs; February 09, 2020
Medical Device School – Process Validation or Verification?
0 secs; February 04, 2020
Episode 61 – Medical Device Regulatory Update: January 2020
0 secs; February 02, 2020
How to register your Device in Brazil with Tania Aprigliano? (ANVISA)
0 secs; January 26, 2020
Why is it Awesome to work in a Quality or Regulatory affairs job?
0 secs; January 21, 2020
How to create a QMS compliant to MDR with Stefan Bolleininger
0 secs; January 19, 2020
How to register your Medical Device through 510k with Michelle Lott
0 secs; January 12, 2020
Medical Device School: How to audit your Suppliers?
0 secs; January 07, 2020
Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
0 secs; January 05, 2020
I wish you a Happy New Year 2020 with Monir El Azzouzi
0 secs; December 29, 2019
6 ways to collect Clinical Data with David Rutledge
0 secs; December 22, 2019
Class I Medical Devices under MDR with Erik Vollebregt (PART 2)
0 secs; December 15, 2019
Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
0 secs; December 08, 2019
How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen?
0 secs; December 01, 2019
Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch
0 secs; November 24, 2019
Medical Device School: Product Development or Documentation creation?
0 secs; November 20, 2019
EUDAMED is delayed, so What? with Richard Houlihan
0 secs; November 17, 2019
Literature Search for your CER with Ed Drower
0 secs; November 10, 2019
Medical Device School: How to build a Gap Assessment Tool?
0 secs; November 06, 2019
How to validate an eQMS with Jacob Sjorslev
0 secs; November 03, 2019
How to implement an eQMS with Jacob Sjorslev
0 secs; October 27, 2019
Medical Device School – Most important issues on your CAPA (ISO 13485)
0 secs; October 23, 2019
Medical Device Disruptions at Hospitals with Stefan Krojer
0 secs; October 20, 2019
5 FDA Myths for Start-Ups with Justin Bushko
0 secs; October 13, 2019
GDPR & MDR for Medical Applications with Jovan Stevovic
0 secs; October 06, 2019
Register your Medical Device in the US with Michelle Lott (FDA)
0 secs; September 29, 2019
New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo
0 secs; September 21, 2019
Learn Post Market Surveillance with Natasha Bankowski
0 secs; September 15, 2019
Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie
0 secs; September 07, 2019
Episode 39 – Networking at Medical Device events with Lynda Wight
0 secs; September 01, 2019
Episode 38 – Be the Best Candidate Ever with Mitch Robbins
0 secs; August 25, 2019
Episode 37 – Usability & Human Factor with Sharon Ayd
0 secs; August 18, 2019
Episode 36 – How to choose your PRRC with Erik Vollebregt
0 secs; August 11, 2019
Episode 35 – Digitalization of QA RA with Michael Kania
0 secs; August 04, 2019
Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
0 secs; July 28, 2019
Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt
0 secs; July 21, 2019
Episode 32 – Pakistan Registration Process with Muhammad Sohail
0 secs; July 14, 2019
Episode 31 – First Regulatory Affairs Job with Karandeep Badwal
0 secs; July 06, 2019
Episode 30 – Promotional Compliance with Darshan Kulkarni
0 secs; June 30, 2019
Episode 29 – 5 Steps to create a QMS with Jason Lim
0 secs; June 23, 2019
Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
0 secs; June 16, 2019
Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
0 secs; June 09, 2019
Episode 26 – IVDR preparation with Andreas Stange
0 secs; June 02, 2019
Episode 25 – EUDAMED secrets with Richard Houlihan
0 secs; May 26, 2019
Episode 24 – Myths about consultants with Thomas McMann
0 secs; May 19, 2019
Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland
0 secs; May 13, 2019
Episode 22 – Clinical Trial with Alethea Wieland
0 secs; May 06, 2019
Episode 21 – How to master Regulatory Affairs with Samantha Alsbury
0 secs; April 29, 2019
Episode 20 – What is a Blockchain with Khuram Malik
0 secs; April 22, 2019
Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
0 secs; April 14, 2019
Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
0 secs; April 07, 2019
Episode 17 – Unannounced audit stories with Florent Guyon
0 secs; March 31, 2019
Episode 16 – From Disease to a Medical Device with Sean Hamilton
0 secs; March 24, 2019
Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
0 secs; March 17, 2019
Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
0 secs; March 10, 2019
Episode 13 – Brexit Talk with Richard Young
0 secs; March 03, 2019
Episode 12 – How to create an ISO Standard with Marcelo Antunes
0 secs; February 24, 2019
Episode 11 – Medical Device Software Validation
0 secs; February 17, 2019
Episode 10 – Understand MDSAP with Angelina Hakim
0 secs; February 11, 2019
Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
0 secs; February 03, 2019
Episode 8 – From Correction to Prevention with ODIAC
0 secs; January 27, 2019
Episode 7 – Make your KPIs Green again
0 secs; January 20, 2019
Episode 6 – What are the 6 types of Medical Device Audits
0 secs; January 12, 2019
Episode 5 – Medtech Prediction 2019
0 secs; January 06, 2019
Episode 4 – UDI for Unique Device Identification
0 secs; December 29, 2018
Episode 3 – Is my Product a Medical Device in Europe?
0 secs; December 20, 2018
Episode 2 – New EU Medical Device Regulation MDR 2017/745
0 secs; December 16, 2018
Episode 1 – Introduction to the Medical Device made Easy Podcast
0 secs; December 14, 2018
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