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At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray,...Read More

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The Device Quality System Regulation (GMP) explicitly requires signatures in the following places: The sections of the regulation which specifically require signatures are: · Sec. 820.30 Design controls.c & d · Sec. 820.40 Document controls a & b · Sec. 820.75 Process validation a · Sec. 820.80 Receiving, in-process, and finished device acceptance d&e. ·...Read More

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