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Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

A session by Carolyn Guthrie
Director of QA / RA, Kapstone Medical

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About this talk

While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.

Talk takeaways: • Understanding the new requirements of PMS under MDR • What is the impact to the business? • How do the requirements affect your current product lifecycle approach/QMS? • Relationship between PMCF and PMS • What to include in your plans and reports?

ABOUT KAPSTONE MEDICAL:

Kapstone Medical, founded in 2007, is a single-source service provider to medical device companies lacking the appropriate human capital to commercialize new and safe products. We offer customized solutions that are flexible and cost-effective in an ever-changing regulatory environment. Our services span five main areas: product development, quality assurance, regulatory affairs, intellectual property strategy, and manufacturing solutions.

Carolyn Guthrie

Regulatory Affairs Certificate (RAC) US

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