Understand IEC 62304 for Software Medical Devices with Adnan Ashfaq

[@mooudamirkavei6007]

Thanks so much Monir and Adnan for very informative video. Hope to see more and more videos on SaMD.

[@josejimeneza5816]

This video is Gold

[@EasyMedicalDevice]

Thanks for your support 🙏

[@priyankap4433]

It was very informative Monir. Please clarify :Do I have to a have a Dedicated QMS(using 13485 or 21CFR 820) for Software as a medical device (SaMed). Thank you Regards Priyanka

[@EasyMedicalDevice]

Yes you need one. For class I no need to be certified but for other classes it should be certified by a notified body

[@priyankap4433]

@@EasyMedicalDevice Many thanks Monir.

[@va222an]

Hi All, What kind of software procedures you follow in Verification and validation testing? Like do we do blackbox testing, Regression testing? Any inputs on test plan?

[@vishwasnagaraju8260]

Very well spoken Adnan.

[@jonathanphillips5514]

Excellent video in what is confusing area! Thanks

[@navdeepgill9729]

Very informative and good coverage, Only One place where i could not follow was @10:10 , There are 4 critical documents required for the IEC62304 ? Please add some more information around that. One i could understand was clinical Management and Risk Management, Can you please explain others aswell.

[@adnanashfaq9163]

The documents are IMDRF - n41 SaMD clinical Evaluation IMDRF - n23 SaMD QMS IMDRF - n10 SaMD Key Definitions IMDRF - n12 SaMD Risk Categorisation

[@navdeepgill9729]

@@adnanashfaq9163 Thanks for the quick response.

[@daithideburca98]

Very informative, would love to see how equivalence is going to be addressed in Software, how would you compare two pieces of samd one approved v a new application

[@EasyMedicalDevice]

I think this is a challenging topic. You should define some criteria that are comparable but will this be enough. I will investigate.

[@pranav203]

I want to sincerely thank you for the very informative video. I’ve been in the medical device quality engineering space and this information is very useful. 👍🏼

[@EasyMedicalDevice]

You‘re welcome

[@vishnudas7839]

Really informative Monir.