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Independent Design Review
A separate, qualified, independent, and objective set of eyes...
We lead or function as an independent member of a design review team. Having an independent reviewer also helps satisfy the requirements called out in CFR 820. We bring an outside perspective to the evaluation and analysis of the human factors, mechanical, electrical and software portions of a design or process. We also help evaluate the documentation associated with a design or process including testing and traceability. We can create or provide guidance in the creation of design history files, device master records, specifications, traceability documentation, design validation and verification for all aspects of the design or process.
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webmaster@bolamcorp.com with
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