EU MDR PMCF Requirements for Medical Devices PMS. PMSR. PMCF. PSUR. CER. If this seemingly endless list of regulatory acronyms makes you dizzy, you're not alone. They all refer to different postmarket surveillance (PMS) activities or processes required to maintain compliance with the EU Medical Device Regulation (MDR 2017/745). As you probably know, the MDR [...]
Oriel STAT is a New Jersey-based consulting firm that provides MDSAP auditing, QMS implementation, private team training, and related services for the medical sector.