FDA part 820 Software Validation - Can software be retrospectively validated?

S

SRavi

Hello George,

Thank you for the prompt reply. I think now I am getting somewhere with the understanding of how the software validation needs to be done in my application. Thank you . That was really helpful and now I have something to go on with. Nevertheless if I am stuck again I will get back here and get some fresh air. :D

DO you have any experience with ISO 10993 regulations ? I am also working on a project where I need to get my hands on some off the shelf material which complies with medical standards of ISO 1099. Let me know I have some quarries there as well.

Really appreciating your help.

Thanks and regards,
Ravi
 
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