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?
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
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. 👍🏼
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
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.
Thanks so much Monir and Adnan for very informative video. Hope to see more and more videos on SaMD.
Very well spoken Adnan.
Excellent video in what is confusing area! Thanks
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?
Really informative Monir.
This video is Gold
Thanks for your support 🙏
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
I think this is a challenging topic. You should define some criteria that are comparable but will this be enough. I will investigate.
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. 👍🏼
You‘re welcome
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
Yes you need one. For class I no need to be certified but for other classes it should be certified by a notified body
@@EasyMedicalDevice Many thanks Monir.
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.
The documents are
IMDRF - n41 SaMD clinical Evaluation
IMDRF - n23 SaMD QMS
IMDRF - n10 SaMD Key Definitions
IMDRF - n12 SaMD Risk Categorisation
@@adnanashfaq9163 Thanks for the quick response.