What are the key elements of an effective post-market surveillance system? With increasing pre-market regulatory requirements, why do we still need post-market surveillance? Watch now to answer those questions and more as we take a broad look at medical device post-market surveillance today and potential challenges for the future.
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.
In this session, Mike Drues, President at Vascular Sciences, will use the case study approach to take a dive into medical device post-market surveillance best practices to teach you how to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage.
★ KEY VIDEO TAKEAWAY★
—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 it is effective and working? Absolutely not!
This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks:
1) GO Track - Covering everything you need to know to get new devices to market with less risk
2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic
The video you’re watching now is from our GROW Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event: [ Ссылка ]
Plus, download the slides from this presentation for free here:[ Ссылка ]
Are you looking for a QMS solution to help you bring safer medical devices to market faster with less risk? Take a quick tour of Greenlight Guru's Medical Device QMS software: [ Ссылка ]
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