RQA GPvP Committee
You may also find this booklet useful : Medical Devices Regulation Booklet (purchasable from RQA).
We suggest to structure a device PV audit very similarly to a drug PV audit (e.g. QMS in place, staff training, incident reporting, management, signal trending processes, RA responsibilities/Registration of device/CE mark, update of Device Information/Marketing Brochures, safety reports from clinical studies, trackers to oversee compliance etc.) - but adjust the incident reporting requirements to the device legislation.