Using Substantial equivalence to demonstrate risk management in the 510(k) submission.Ī predicate device is a legally marketed device subjected to premarket approval. What are the contents of risk related documentation?.Contents of software related documentation?.Key factors for documenting risks before submitting 510(k)?.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?.
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