Blog articles25 May 2021 Post-Market Surveillance (PMS): What You Need to Know and Do Now Post-market surveillance (also known as Post-Marketing Surveillance or PMS) refers to the requirement that manufacturers monitor their medical… Learn more
Blog articles15 March 2021 RWE and PMCF: The Role of Registry Studies and PROs Registry studies focused on a specific medical device are a valuable tool to capture the safety and outcomes of the device over its lifetime. Read more here. Learn more
Blog articles28 April 2020 The Impact of ISO 14155 on PMCF Investigations Under the MDR Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with… Learn more
Blog articles24 April 2020 Impact of COVID-19 and the Imminent MDR Delay Introduction The implementation of the new EU Medical Device Regulation (MDR) just got a plot twist: COVID-19. This… Learn more
Blog articles6 April 2020 Forecasting the impact of COVID-19 on medical device trials As of early April 2020, over 1,000,000 people have been confirmed infected with the SARS-CoV-2 coronavirus, and governments… Learn more
Blog articles5 March 2020 How to use ePROs and Physician Surveys to fulfill MDR PMCF requirements in 6 steps To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance… Learn more
