Medical device companies face an expanding set of legal and regulatory requirements to address risks and concerns around product safety. Scrutiny from the public and regulators increasingly focuses on safety concerns, as demonstrated by the FDA’s recent changes to the 510(k) process and draft guidance for post-market safety. As product safety requirements increase, device companies must expand their approach to both post-market safety surveillance and managing product risks.

In a passive system — like the one that has historically dominated the industry — manufacturers rely on data reported by healthcare providers or patient complaints. In light of the growing complexity of medical devices, this system — characterized by passively acquired data, often received too late in the game — is no longer sufficient to ensure product safety.

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