Transition to Agile for Software as Medical Device
We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster. ...
25 Apr 20230s
Prepare your audit like a PRO
If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep ...
18 Apr 20230s
What is a SOUP for your Software Development?
In this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what...
11 Apr 20230s
Medical Device News – March 2023 Regulatory Update
► Medboard platform: https://www.medboard.com/ ► Podcast page: https: //podcast.easymedicaldevice.com/226-2/ ► MEDBOARD SHOW NOTES LINKS: https://www.medboard.com/reports/easy-medical-device-regul...
4 Apr 20230s
How to perform Risk Management for a Software ?
In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book […] The post How to perform Risk Managemen...
28 Mars 20230s
How to create a Proactive Postmarketing Surveillance? [EU MDR]
The postmarketing surveillance is a major process within the EU MDR. Today Marcus Emne from Hoodin will explain to us how this is working and how the Artificial intelligence may help. The post How to ...
21 Mars 20230s
What you should know about Vigilance Reporting for Medical Devices?
Vigilance Reporting is one of the process that everyone should have but that no one wants to use. So this is really difficult to understand all the requirements to it. Also knowing that this may chang...
14 Mars 20230s
Medical Device News: March 2023 Regulatory Update
A lot of information within this update. So check the show notes as this may be a bit too much for you. This March Update is going through Europe but also US, Middle East, South Africa. A world tour. ...
8 Mars 20230s
