Medical device companies that identify quality problems early on can prevent product development costs from spiraling out of control, while also laying the groundwork for design verification and ...
From my product development experiences, entering into Design Verification and Design Validation is always bittersweet. Exciting because yes, to get to Design Verification means that we have ...
FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...
THE ASSESSMENT OF COMPANY-LEVEL CONTROLS is a critical part of complying with section 404 of Sarbanes-Oxley. The PCAOB says public companies must assess the design and operating effectiveness of these ...
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