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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...
RSP Systems
Diabetes patients are recommended to test their blood sugar levels 4 to 10 times per day depending on...
ZEISS
ianTECH Inc. is a medical device company based in the United States that develops surgical devices, methods and...
4 reasons why having a single EDC system for your device company makes sense
CEOs of medical device companies have an intuitive sense of what they need from their clinical data. However,...
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