Medical Device made Easy Podcast

Did you had this blank in your head when an auditor asked you the validation documents of your software? I know your pain. So today we will try to help you validate your software with some automation....

15 Aug 20230s

We feel your pain when your bosses ask you to hire a QA RA person, but the challenge is that there is no Budget for it. But you want to impress them, so what to do. In this episode Mitch Robbins a pro...

8 Aug 20230s

Everyone is talking about Risk Management file and ask you to provide that to them. But should you do that alone or identify the best partners on your team to be successful. This is what Naveen Agarwa...

1 Aug 20230s

There is still this misunderstanding about AI, and we wanted to discuss about AI for Medical Devices to really understand what this is. I have invited Christophe Girardey from Wega to put some light i...

25 Juli 20230s

Software validation when used on patient is common and mandatory. But now when we tell you that you should validate also the software you are using to record your documents, CAPAs, or work on the elem...

18 Juli 20230s

Saudi Arabia is a major actor in the Medical Device world. A lot of companies are willing to enter this market that can help them to reach also other regions of the Middle East. We will discuss with A...

11 Juli 20230s

july 2023regulatory update The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

4 Juli 20230s

UK decided to add more time to implement the UKCA. Apparently, the EU amendment to extend the EU MDR and IVDR was also something they looked at to define their timeline. So, let’s see what will this m...

27 Juni 20230s