FREE ON-DEMAND WEBINAR
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive
This webinar will focus on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) set to go into enforcement in May 2020.
These new PMS requirements push the manufacturer 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.
Analysis of data to ensure appropriate actions are taken, such as updating technical documentation or device improvements, is performed according to predefined criteria.
During this free 60 minute webinar hosted by Carolyn Guthrie, Director of QA/RA at Kapstone Medical, you will 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.