FDA QSR Requirements - Checklist for Class II Medical Device Contract Manufacturer

[Medsearch]

[FONT=&quot]Hi Everyone[/FONT]

[FONT=&quot]We are the design, manufacturer of class II medical devices, for manufacturing part get it done from contact manufacturer. We are going to submit 510(k) registration but no GMP exempt. We have to follow FDA QSR requirements. [/FONT]

[FONT=&quot]Can you please share what contact manufacture should meet as per FDA QSR requirements?[/FONT]

[FONT=&quot]Can you please share a check list for this?[/FONT]

 

[Jen Kirley]

Re: Checklist for contract manufacturer

Whoever manufactures the device would need to conform to FDA criteria. If you are asking for an audit checklist to certify a supplier and the Cove's Post Attachments (did you try a search by clicking on the green button in the header?) and we can't provide, commercially available materials like this one are available.