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.

Specifically this webinar will cover: 

• 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?
• Q&A Session

Who should attend?

• Medical Device Executives
• Product Development Engineers
• Product Managers
• Regulatory Affairs Professionals
• UX Designers