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
Blog28 April 2020 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
Blog24 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
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
Blog6 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
Blog5 March 2020 6 Steps for Using ePRO & Physician Surveys to Fulfill MDR PMCF To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance… Learn more
Blog23 January 2018 How we’re gearing up for GDPR In the past two decades, technology has drastically changed how we capture, use, and store data. As a… Learn more
