C
C Jones
Associates,
I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types.
I know there's some flexibility in who the organization identifies as required signatories on documents per their defined colleague's responsibilities, but does the Agency expect specific representation on DHF documents?
For example, my HFE/UE should probably have a medical/clinical approver, and my pFMEA should have a manufacturing lead, but each likely doesn't require signing off on the other document. Is a QC and regulatory lead required for all design control documents? Author? Project lead? Senior director?
For what it's worth, we're a 3 person startup wearing a lot of hats.
Thank you in advance-
I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types.
I know there's some flexibility in who the organization identifies as required signatories on documents per their defined colleague's responsibilities, but does the Agency expect specific representation on DHF documents?
For example, my HFE/UE should probably have a medical/clinical approver, and my pFMEA should have a manufacturing lead, but each likely doesn't require signing off on the other document. Is a QC and regulatory lead required for all design control documents? Author? Project lead? Senior director?
For what it's worth, we're a 3 person startup wearing a lot of hats.
Thank you in advance-