What are the contents of risk related documentation? Key factors for documenting risks before submitting 510(k)?Ĭontents of software related documentation? How can manufacturers demonstrate device safety? Where can one find 510(k) risk management requirements? Risk management requirements for a Traditional 510(k)? Types of devices needing risk management for 510(k) submissions? What is a predicate device and how to claim substantial equivalence to a proposed device? Here is a list of questions we should understand: The blog describes key factors for documenting risk management in 510(k) submissions. To legally market your medical device, you need to demonstrate it is as safe and effective as any other legally marketed product that is not subject to PMA (21 CFR 807.92(a)(3)). You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to support substantial equivalency claims.
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