Test reports should document objectives, acceptance criteria, material & methods, results protocol deviations and conclusions. If test results are considered representative for a group of devices (i.e. worst case devices or comparative devices), then a justification for leveraging protocol(s) and report(s) should be provided. Similarly, if testing has been undertaken on prototypes or devices that otherwise do not represent the finished goods, a justification for the adequacy of this testing should be provided. If multiple design verification / validation studies were conducted please provide a flow chart or table that shows how the studies were conducted and highlight which study ultimately demonstrates that the design meets the product performance specifications.
Hello, everyone. How to understand leveraging protocol in this context? Can I understand as "quote"? thx
Hello, everyone. How to understand leveraging protocol in this context? Can I understand as "quote"? thx
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