PSUR Authoring 

The Periodic Safety and Update Report, a crucial PMS requirement for all medical device manufacturers 

The Medical Device Regulation (MDR) 2017/745 introduced the Periodic Safety and Update Report (PSUR) as a requirement by Medical Device Manufacturers for all class IIa, class IIb and class III devices. It’s meant to be a more consistent, standardized and systematic review of all Post-Market Surveillance (PMS) data for these classes of devices so as to maintain the PMS regulatory requirements. 

Our team of specialists develop PSURs in accordance with MDCG, observing these key document structural components and conformity measures: 

• Based on objects of device specific post market reporting requirement

• In line with client specific quality management systems

• Comprehensively evaluated with well aggregated clinical data

• Account for all the devices in scope of the current PMS evaluation

• Account for the identification and evaluation of all the changes to the risk benefit profile of the medical device with respect to classification