ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

PMS and ISO 13485 relationship with MDR

The Post Market Surveillance Procedure complies with MEDDEV 2.12/1, European Medical Device Regulation MDR 2017/745, (EN) ISO 13485:2016.

New MDR Post Market Surveillance requirements and interacting systems find difficult and hard challenge. To initiate the process develop a new QMS process interaction diagram as above with the help of expert hands.

PMCF