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Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Marked, is that Device Safe and Effective?

A session by Michael Drues
President, Vascular Sciences

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About this talk

When a medical device is FDA Cleared/Approved or EU CE Marked, can we assume it’s safe and effective? In a word... NO! Post-market surveillance (PMS) is the process of watching devices perform while on the market. PMS is a vital component of the medical device lifecycle. Yet the med-tech industry has had a poor record when it comes to PMS. As a result, PMS requirements have been increasing in the US, the EU and around the globe.

Having an effective PMS system is important from both a regulatory and quality perspective. But can we assume if our PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not! This presentation will use the case study approach to take a broad look at medical device post-market surveillance including:

• What are the key elements of an effective PMS system?

• With increasing pre-market regulatory requirements, why do we still need PMS?

• Is passive PMS enough? What about active PMS?

• How can PMS be used for label expansions? Either via RCT and/or real-world evidence?

• What are the PMS challenges for the future? In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!