Medical Device Design Verification SOP
Medical Device Design Verification SOP
Design Verification
Verification Protocols Verification Reports Design Review documents
Each of these deliverables shall be approved by the PL/HE and Quality Assurance. Design Review documents shall also be approved by the DRC.
7.3 Design Output
The Design Outputs and Verification Matrix demonstrate traceability between each Product Requirement and the Verification Results. It is a summary of the Verification Phase. Design Outputs Verification Matrix The first three columns of the Design Outputs and Verification Matrix were populated during the Design Output Phase: Requirements Paragraph Number Design Output Document Number Verification Method
As Verification Tests are completed, Verification Test Report Numbers are entered into column four. If Design changes are necessary, the numbers of the documents that describe the change are entered into column five.
7.4 Design Verification Matrix (detail)
The Design Verification Detail Matrix provides details of each test associated with each Product Requirement. Product Requirements (column 1) - list the Product Requirement number Verification Protocol# (column 2) - list the title and number of the Verification Protocol Responsible Party (column 3) - the person or group responsible for the Verification is listed Verification Method (column 4) - the Verification method (inspection/test approach) is described. In this section a summary of the activity to be performed to verify the requirement is described. Activity details are entered into the Protocol. Non-conformances (column 5) - enter YES if non-conformances were found during the test; otherwise enter NO Non-conformance Responsibility (column 6) - enter person or group responsible for nonconformance resolution Resolution Due Date (column 7) - enter due date for non-conformance resolution Non-conformance Resolved (column 8) - enter YES if non-conformance was resolved satisfactorily.
Document ID XX_WWW_ZZZ_YYYY
Version 1.0
Status Approved
Page 9/18
Copyright by QMdocs 2010 Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.