PLANNING AN EFFECTIVE POST MARKET SURVEILLANCE PROGRAM FOR MEDICAL DEVICES, Horsholm, Denmark, 3 October 2017
3 October 2017
Medicoindustrien is the Danish medical device industry association, and it holds regular training seminars for its members on device-related regulatory and associated matters. Following demand from its members, the Association held a one-day training event on the subject of post-market surveillance (PMS), covering subjects including:
The regulatory and business backgrounds
Defining a PMS strategy
Integrating PMS with the quality system
New requirements under the Medical Device Regulation
The speaker was Roger Gray, VP Quality and Regulatory, Donawa Lifescience Consulting. Pia Wissing Jensen, Chair of the Medicoindustrien PMS Group, also contributes a presentation on a practical approach to meeting the regulatory requirements.