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Medical Device Design Verification SOP

Quick Overview This Standard Operating Procedure (SOP) describes the procedures verifying a Product’s design through appropriate inspection, testing, analysis, and review. This Verification ensures the Product Requirements, which are defined during the Design Input phase of Design Control, have been met.

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0% found this document useful (1 vote)
4K views1 page

Medical Device Design Verification SOP

Quick Overview This Standard Operating Procedure (SOP) describes the procedures verifying a Product’s design through appropriate inspection, testing, analysis, and review. This Verification ensures the Product Requirements, which are defined during the Design Input phase of Design Control, have been met.

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qmdocs
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Quality Management

Documents & Templates

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 Type SOP

Document ID XX_WWW_ZZZ_YYYY

Version 1.0

Status Approved

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