Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Episoder(403)

Episode 35 – Digitalization of QA RA with Michael Kania

Episode 35 – Digitalization of QA RA with Michael Kania

Digitalization of QA RA is a concept that many Medical Company didn't adopt. But what can they win if they engage on it? This is the topic of today´s episode. The post Episode 35 – Digitalization of ...

5 Aug 20190s

Episode 34 – Real-World Data for Medical Devices with Alethea Wieland

Episode 34 – Real-World Data for Medical Devices with Alethea Wieland

Real World Data is more and more important with all the new devices that can collect them. Then what can we do with them and how to present them to a regulator. The post Episode 34 – Real-World Data f...

29 Jul 20190s

Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt

Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt

One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the co...

22 Jul 20190s

Episode 32 – Pakistan Registration Process with Muhammad Sohail

Episode 32 – Pakistan Registration Process with Muhammad Sohail

Pakistan Registration requirements for Medical Devices have been improved and leave more opportunities for Manufacturers. Muhammad Sohail, will share with us the situation of this market and the steps...

14 Jul 20190s

Episode 31 – First Regulatory Affairs Job with Karandeep Badwal

Episode 31 – First Regulatory Affairs Job with Karandeep Badwal

Finding your first Regulatory Affairs Job can be a challenge. And Karandeep Badwal knows about that as he followed this journey. He is now Regulatory Affairs Contractor. Karandeep wanted to share with...

6 Jul 20190s

Episode 30 – Promotional Compliance with Darshan Kulkarni

Episode 30 – Promotional Compliance with Darshan Kulkarni

The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products. The p...

30 Jun 20190s

Episode 29 – 5 Steps to create a QMS with Jason Lim

Episode 29 – 5 Steps to create a QMS with Jason Lim

Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS. The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made ...

23 Jun 20190s

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2

How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast. The po...

16 Jun 20190s

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