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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...
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...
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...
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...
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...
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...
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...
6 Steps for Using eCOA / 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...
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...
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