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Medical Device made Easy Podcast
Listen Medical Device Regulation and Standards
What to learn about the EU Medical Device situation? [Erik Vollebregt]
0 secs; May 23, 2022
What happens after the IVDR Date of Application with Colm O’Rourke
0 secs; May 16, 2022
How to certify your Software as a Medical Device? (SaMD)
0 secs; May 09, 2022
Medical Device News: May 2022 Regulatory Update
0 secs; May 02, 2022
Training Process – What are the mistakes to avoid? [ISO 13485]
0 secs; April 25, 2022
How your PMCF is evaluated by your Notified Body? [Matthias Fink]
0 secs; April 18, 2022
How to prepare an Audit with a Front Room & a Back Room?
0 secs; April 11, 2022
Medical Device News: April 2022 Update
0 secs; April 04, 2022
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
0 secs; March 28, 2022
How to sell Medical Devices online in the EU and US?
0 secs; March 21, 2022
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
0 secs; March 14, 2022
Why do we need the Common Specification for Class D IVDR?
0 secs; March 07, 2022
Medical Device News – March 2022 Regulatory Update
0 secs; February 28, 2022
Why would you need a Swiss Authorised Representative and Importer?
0 secs; February 21, 2022
How to be great at Management Reviews? [ISO 13485]
0 secs; February 14, 2022
Why Design History File (DHF) is so important? [Alexandros Savvidis]
0 secs; February 07, 2022
Medical Device News: February 2022 Regulatory Update
0 secs; January 31, 2022
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
0 secs; January 24, 2022
How to interview your QA RA Candidates? [Mitch Robbins]
0 secs; January 17, 2022
How to accelerate your Laboratory Test Results? [Christoph Lindner]
0 secs; January 10, 2022
Medical Device News – January 2022 [Happy New Year]
0 secs; January 03, 2022
What happened in 2021? Summary for the Medical Device Industry
0 secs; December 27, 2021
The Step-by-Step recipe to get MDR & IVDR Certified
0 secs; December 20, 2021
Which devices cannot be Custom-made? [Erik Vollebregt]
0 secs; December 13, 2021
Medical Device News: December 2021 Regulatory Update
0 secs; December 06, 2021
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
0 secs; November 29, 2021
How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
0 secs; November 22, 2021
Is it possible to Private Label a Medical Device under MDR & IVDR?
0 secs; November 15, 2021
How to improve your QA RA Communication with Lesley Worthington?
0 secs; November 08, 2021
Medical Device News – November 2021 latest update
0 secs; November 01, 2021
How does the EU Commission plan to save IVDR 2017/746?
0 secs; October 25, 2021
How to comply with MDR when products contain CMR Substances?
0 secs; October 18, 2021
EUDAMED Update: Should you register your medical devices now?
0 secs; October 11, 2021
Medical Device News – October 2021 Regulatory Update
0 secs; October 04, 2021
Why does an Importer/Distributor need to appoint a Notified Body?
0 secs; September 27, 2021
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
0 secs; September 20, 2021
How to manage the IVDR transition period? [IVDR 2017/745]
0 secs; September 13, 2021
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
0 secs; September 06, 2021
Medical Device News – September 2021 Latest Updates
0 secs; August 30, 2021
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
0 secs; August 23, 2021
Better to be a Consultant or a Full-time employee? [Lifescience industry]
0 secs; August 16, 2021
What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
0 secs; August 09, 2021
Medical Device News – August 2021 Regulatory Update [MDR & IVDR]
0 secs; August 02, 2021
How to implement Vigilance Reporting for MDR and IVDR?
0 secs; July 26, 2021
System and Procedure Pack the RETURN with Erik Vollebregt
0 secs; July 19, 2021
How to interpret the first Expert Panel Opinion? [Bassil Akra]
0 secs; July 12, 2021
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
0 secs; July 05, 2021
How to build your State-of-the-art for your Medical Devices?
0 secs; June 28, 2021
How Intellectual Property is linked to the Medical Device Regulation?
0 secs; June 21, 2021
How to perform a good Clinical Investigation with Helene Quie
0 secs; June 14, 2021
How to perform a Biological Evaluation for your Medical Device?
0 secs; June 07, 2021
Medical Device News – June 2021 Update [EU MDR Date of Application]
0 secs; May 31, 2021
EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]
0 secs; May 24, 2021
MDR is coming so brace yourself with Erik Vollebregt
0 secs; May 17, 2021
FDA: Is the Emergency Use Authorization worth it? (EUA)
0 secs; May 10, 2021
Medical Device News – May 2021 Update [EU MDR 2017/745]
0 secs; May 03, 2021
Checklist – What is important before the EU MDR Date of Application?
0 secs; April 26, 2021
How to perform correctly a Merger & Acquisition during the MDR transition?
0 secs; April 19, 2021
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
0 secs; March 29, 2021
How to create a Label under MDR? (Questions & Answers)
0 secs; March 22, 2021
How System and Procedure Pack are regulated under EU MDR?
0 secs; March 15, 2021
How to import your Medical Devices with an Independent Importer?
0 secs; March 08, 2021
What is the Medical Device News? [March 2021 update]
0 secs; March 01, 2021
The best design methods for successful development? [Jon Speer]
0 secs; February 22, 2021
How to find a QA RA job for Medical Devices? [Karandeep Badwal]
0 secs; February 15, 2021
What is the QA RA Mindset with Michelle Lott
0 secs; February 08, 2021
February 2021 Update – Medical Devices Remote Audit by the EU
0 secs; February 01, 2021
How to perform your PMS more easily with Ivan Perez Chamorro?
0 secs; January 25, 2021
How to get the MDR certification for Artificial Intelligence Softwares?
0 secs; January 18, 2021
How to register a Medical Device in Israel? (Liat Nadel)
0 secs; January 11, 2021
Medical Device News – January 2021 Update (Monir El Azzouzi)
0 secs; January 05, 2021
How Easy Medical Device can help you? (Monir El Azzouzi)
0 secs; December 27, 2020
How to deal with Significant Changes within MDR & IVDR with Martin Witte
0 secs; December 20, 2020
How to register a Medical Device in Mexico? [Josué Garza]
0 secs; December 13, 2020
Medical Device News: What happened in November 2020?
0 secs; December 06, 2020
Is it Easy for a Notified Body to get EU MDR accredited?
0 secs; November 29, 2020
How a Quality & Regulatory training can help you? [Sofmedica]
0 secs; November 22, 2020
Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
0 secs; November 15, 2020
What are Common Specifications under EU MDR & IVDR?
0 secs; November 08, 2020
We’ve reached episode 100 – What happened for the last 2 years?
0 secs; November 01, 2020
How to certify a self-testing device under IVDR? [Erik Vollebregt]
0 secs; October 25, 2020
What is the cost of EU MDR 2017/745? [Catherine Higginson]
0 secs; October 18, 2020
How to register your Medical Device in the ASEAN region?
0 secs; October 11, 2020
The latest news on Brexit, Swixit and EU MDR [Medical Device News]
0 secs; October 04, 2020
How to register ATMP-Device combination products?
0 secs; September 27, 2020
How to get some help from Medical Device Regulators with Cliff Bleustein
0 secs; September 20, 2020
How can GDPR impact Medical Devices with Erik Vollebregt
0 secs; September 13, 2020
Be successful at your MDR and IVDR audit with Martin Witte
0 secs; September 06, 2020
Medical Device News – August 2020 Review (Monir El Azzouzi)
0 secs; August 30, 2020
How to switch quickly to a Virtual Conference with TOPRA
0 secs; August 23, 2020
Best practice for Device Testing with Michael Wetherington
0 secs; August 16, 2020
Best overview of IEC 60601 for Medical Device electrical equipment
0 secs; August 09, 2020
Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
0 secs; August 02, 2020
Learn UDI code for Medical Devices with Sylvia Reingardt
0 secs; July 26, 2020
Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
0 secs; July 19, 2020
How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
0 secs; July 12, 2020
Medical Device News – June 2020 Update
0 secs; July 05, 2020
The secrets to being EU MDR certified with Shokoufeh Khodabandeh
0 secs; June 28, 2020
How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
0 secs; June 21, 2020
How to execute your Internal Audits? (Medical Device companies)
0 secs; June 14, 2020
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