
How to select and evaluate your Contract Manufacturer?
Sometimes, you want to manufacture a product but you don’t have the capacity or even the infrastructure. Then why not asking a Contract Manufacturer to do that for you. Let’s explain to you what you s...
14 Mai 20240s

Quality Field Service for Medical Devices
Some of you may think that Field Service has nothing to do with Quality or Regulatory Affairs, but after this episode you may see some links and you may understand how this is working. Listen to Micha...
7 Mai 20240s

Medical Device NewsMAY 2024 Regulatory Update
EU Article to read Training Events Rest of the world Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc...
2 Mai 20240s

Why and how to build a Quality Culture?
You may think that this is a nice to have but after listening to that you’ll have the arguments to convince your company to build it. Check this episode with Lesley Worthington and start the creation ...
23 Apr 20240s

What is the impact of AI Act on Medical Devices?
We talked a lot about the AI ACT and now it becomes reality. This is or will be live soon. But what are the consequences for Medical Device manufacturers who are using Artificial Intelligence for thei...
16 Apr 20240s

Radiation Sterilisation Master File (ISO 11137 & 11607)
Adam will inform us about the documentation needed for building your Sterilisation master file specifically for radiation sterilization. Check this out. The post Radiation Sterilisation Master File (...
9 Apr 20240s

Medical Device News April 2024 Regulatory Update
Sponsor: Medboard: https://www.medboard.com/ EU UK Ireland Turkey Events Services ROW USA Australia Saudi Arabia Brazil India Malaysia China Podcast Easy Medical Device Social Media to follow The post...
4 Apr 20240s

How to benefit from Surveys to build Clinical Evidence?
On this episode, Steve Curran from Trinzo will help us understand how to be better at doing your Postmarketing Surveillance. The post How to benefit from Surveys to build Clinical Evidence? appeared ...
26 Mar 20240s



















