Planning an effective post market surveillance program for medical devices
The course will concentrate on European requirements but will also touch on US FDA expectations and the links between PMS and vigilance reporting.
In today’s regulatory context, post market surveillance (PMS) is a necessary part of the medical device life-cycle, requiring analysis of information from both reactive and proactive sources and its integration with the device risk management program in order to maintain regulatory compliance. Increased enforcement of device regulation is an inevitable consequence of recent publicity concerning higher risk devices, but manufacturers should be aware that PMS requirements apply to all classes of device under European legislation.
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 concentrate on European requirements but will also touch on US FDA expectations and the links between PMS and vigilance reporting. The course will provide the knowledge to allow delegates to develop their own PMS strategies and will include ample time for delegate interaction and discussion.
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:
- Quality Assurance
- Clinical Affairs
The course will be conducted in English.
"It confirmed me in what I was working on in regards to PMS, and gave new inspiration on how to approach and conduct it" Participant, Fall 2015