What impact do the new requirements of post-market surveillance under EU MDR have on your business? How do the requirements affect your QMS and product lifecycle approach? Watch now to learn what you can do to proactively address the requirements for post-market surveillance under EU MDR.
These new post-market surveillance requirements push manufacturers to take a more active role in monitoring their devices to ensure that the benefit-risk profile of the device remains current.
In this video Carolyn Guthrie, Director of QA/RA at Kapstone Medical, explains why it is important that post-market surveillance is not a one-size-fits-all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
★ KEY VIDEO TAKEAWAY★
- Performing post-market surveillance 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.
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
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