EU MDR 2017/745 POST-MARKET SURVEILLANCE TRAINING – upon request
(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)
Post-Market surveillance (PMS) serves as a key process in the EU MDR. PMS will have additional requirements and undergo additional scrutiny in the incoming regulations. In this training session, you will understand how to gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime of the device to demonstrate conformance to the EU MDR actively and systematically. This training will prepare you for the smooth integration of PMS in day-to-day operations and help you fully understand the changes to the PMS and PMCF requirements caused by the new EU MDR.
• Opening remarks
• Introduction to EU MDR
• Requirements presented under EU MDR for PMS
• PMS Plan, PMS Report, PSUR and linkage to SSCP
• Considerations and common issues for PMS
• How to streamline your approach to PMS under EU MDR
• Linkage to the QMS requirements and EUDAMED
• Q&A session
• Closing remarks
- Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF