Planning an effective post market surveillance program for medical devices
The course will concentrate 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 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, 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 current (Medical Device Directive, MDD) and forthcoming (Medical Device Regulation, MDR) 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, 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 future MDR requirements, 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:
The course will be conducted in English.
"I specifically liked the presentation on new requirements under the MDR and the input on training of sales and marketing. Instructor is very competent and a skilled communicator"
"It gave me a bigger perspective about what Post Market Surveillance really mean"
Participants, Fall 2017