Episode 36 – How to choose your PRRC with Erik Vollebregt
PRRC means Person Responsible for Regulatory Compliance. With the new Medical Device Regulation it is mandatory to have one at your company. Let's review everything about this role and help you to cho...
12 Elo 20190s
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 Elo 20190s
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 Heinä 20190s
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 Heinä 20190s
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 Heinä 20190s
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 Heinä 20190s
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 Kesä 20190s
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 Kesä 20190s
