Purpose and outcome
The purpose of this course is to provide you high level details on regulatory requirements on post market surveillance (PMS) and vigilance on medical devices and combination products and how to ensure regulatory compliance when marketing medical devices and combination products in EU and US.
 
After the course, you will have essential knowledge and skills within PMS and vigilance regulatory requirements on how to conduct a PMS plan, report and PSUR and MIR reporting.

Content
In today’s regulatory context, post market surveillance is a necessary part of the medical device and combination products life-cycle, requiring analysis of information from both reactive and proactive sources, and its integration, under the quality system, with the device risk management and clinical evaluation programs, in order to maintain regulatory compliance. Increased enforcement of device regulation is an inevitable consequence of publicity in recent years concerning higher risk devices, but manufacturers should be aware that PMS requirements apply to all classes of device under both (Medical Device Directive, MDD) and (Medical Device Regulation, MDR) European legislation. Furthermore, manufacturers should also take into consideration EU MDR when it comes to drug-device combination products in the EU.
 
Regulatory authorities expect manufacturers to have a PMS plan for each device family, and for the feedback obtained to be used effectively in managing device-associated risks. The ideal PMS program should not only gather data relative to current production, but also identify consumer needs for continued product development.

The course will focus on European requirements, in particular the significantly increased PMS requirements under the MDR, but will also touch on US FDA expectations, and the links between PMS and vigilance reporting. In addition, under the MDR, transition periods differ, depending on the exact circumstance of device classification and notified body certification involved. This course will provide the knowledge to allow delegates to develop their own PMS strategies to meet MDR requirements and will include ample time for delegate interaction and discussion.

You will get the opportunity to mail specific questions before hand which the trainer will address during the course.

Who should attend?
Post market surveillance touches many functions within the medical device industry, so personnel from the following functions will benefit from the course:

• Regulatory
• Safety
• Quality Assurance
• Clinical Affairs
• Marketing

Trainer
Linda Matti, MSc.Pharm - Certified process consultant - Certified ISO 13485 auditor

"A very experienced trainer able to answer to questions with real life examples"

"Very interactive"

"Really liked the translation/comparison of MDR terminology to PV terminology"

"Instructor had a lot of experience"

"Good level of discussions, group work and presentations" 

Participants, Fall 2023