‘Post market surveillance, Vigilance and Handling communication with competent authorities’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

This item addresses Vigilance and Handling communication with competent authorities (ISO 13485:2016 §8.2.3) and Post market surveillance (ISO 13485:2016 §8.2.1)

Please download for further reading : CPDS global QMS : PMS, vigilance and communication with CA