1. for performing a design review, should we have the document in signed off form?
or can we perform design review on 'draft' version of document
2. how do you handle the open / review points from design review., i.e., how and where do you justify for having them open for a given stage.
viz., certain closure/response to "MAUDE database related points" in design inputs is dependent on update from supplier of device component.
hence it could be parked for closure before design validation or commercialization. ( where should i document the justification that it does not affect other aspects of design control activities. viz., design verification, design output, etc)
or can we perform design review on 'draft' version of document
2. how do you handle the open / review points from design review., i.e., how and where do you justify for having them open for a given stage.
viz., certain closure/response to "MAUDE database related points" in design inputs is dependent on update from supplier of device component.
hence it could be parked for closure before design validation or commercialization. ( where should i document the justification that it does not affect other aspects of design control activities. viz., design verification, design output, etc)