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smitshah replied to the topic Why VERIFICATION is important? and Your ideas to improve Verification process ? in the forum Introduction to Design Controls 7 years, 7 months ago
Verification is the most important part in any project especially even in medical devices where there is interaction between devices and humans. Verification would make sure that device works in accordance with specification laid out in DSD. It all would make sure that all your inputs and out are in check whether all are in accordance with DID and DOD. If we have any issues or any error we can correct our DSD so as to follow FDA regulation. This would also make sure that device design is scrutinized under verification so that device quality is improved any will not be compensated at any point.
Good preparation of Design verification
Design verification Planning
Design verification Developing
Design verification Execution
Design verification ReportDuring the development stage of specification, the identification of verification activity is done parallel. This enables the designer to make sure that the specification is verifiable. So a test engineer can start detailed test plan and procedures. Any changes in specification should be communicated.
Planning for verification is concurrent activity with core and development teams. This occurs throughout the project life cycle. This will be updated as and when any changes are made to design inputs.
The design inputs must be developed including simplest verification activities which are unambiguous and verifiable.
The test procedures created during the development phase is executed in accordance with the test plan, strictly following them in verification activity.
This activity is performed at the end of each phase of verification execution.
The design verification report gives the detailed summary of verification results which includes the configuration management, test results for each type of testing and issues found during the verification activity.If all the activity mentioned above are followed than there is no reason to have any issues with the process.