Understand IEC 62304 for Software Medical Devices

If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from Simplimedica to explain to us what is this standard. He will also mention some key links to the EU MDR 2017/745 and to other standards. Here are some of the questions asked:

  • Which medical device companies should use IEC 62304
  • Do I need to be a Software developer to be able to work on IEC 62304?
  • What is the difference between software classification provided by IEC 62304 and EU MDR 2017/745.

Adnan is offering also a document to download which will help you during your projects with this standard.