R
RobertB123
Hi All,
I am curious as to how members here are going about meeting the requirement for verifying CAs and PAs do not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device (8.5.2 e) and 8.5.3 d))? Do auditors want to see a checkbox with a sign off from a member of RA/QA? What documentation (if any) would you provide as objective evidence that a proper verification was performed?
Thanks in advance,
Robert
I am curious as to how members here are going about meeting the requirement for verifying CAs and PAs do not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device (8.5.2 e) and 8.5.3 d))? Do auditors want to see a checkbox with a sign off from a member of RA/QA? What documentation (if any) would you provide as objective evidence that a proper verification was performed?
Thanks in advance,
Robert