White papers & guides16 June 2020 Satisfying PMCF requirements by utilizing IIS data This white paper describes an approach that would enable medical device manufacturers to leverage anonymous data from IIS projects to support the fulfilment of PMCF data requirements. Learn more
White papers & guides19 May 2020 6 essential steps to ensure Medical Device Regulation (MDR) compliance before May 2021 July 17th 2020: This document has been updated to reflect regulatory changes in response to COVID-19. As this… Learn more
White papers & guides5 May 2020 What does the Medical Device Regulation (MDR) tell us about Post-Market Surveillance? With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for… Learn more
White papers & guides28 April 2020 Three expected changes to FDA medical device approval 2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul… Learn more
White papers & guides21 April 2020 4 ways the Medical Device Regulation (MDR) will impact your device studies Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As… Learn more
