![]() ![]() The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF." ![]() Design validation shall include software validation and risk analysis, where appropriate. ![]() Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Each manufacturer shall establish and maintain procedures for validating the device design. This question commonly arises out of the specific mention of the phrase "risk analysis" in 820.30(g) Design Controls referenced in the bolded text below. We've summarized where the confusion stems from and how and where regulators require risk analysis below. ![]() But the topic requires a more nuanced discussion. It's a question that, even after careful consideration, can seem difficult to answer: Does the FDA actually "require" medical device manufacturers to perform risk analysis? If so, where? ![]()
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