Planning and Process for Compliant Post-Market Surveillance
IMed Consultancy Ltd
QA/RA Medical Device & IVD Consultancy UKRP - QMS - MDR - IVDR - ISO 13485 - CE Marking - Global Submissions - UKCA
Deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation have been pushed back once more.
The following requirements, however, have been active since 26th May 2021i:
Far from being a good moment for manufacturers to rest on their laurels, this is the perfect time to focus on perfecting PMS processes for compliance. This latest blog looks at the need to create specialist teams and processes dedicated to PMS in order to protect patients and brand reputation as well as to secure competitive advantage on the market.
Discover more in our blog or, alternatively, reach out to us directly for tailored, specialist support that takes the pressure off your in-house teams and write to [email protected]