Blog24 July 2020 Jumpstart Your Medical Device Preclinical Phase The path to market for medical devices can be fraught with obstacles. One of the first challenges confronted… Learn more
Blog16 June 2020 Protocol Deviations in Clinical Trials: Understanding the FDA’s Guidance Protocol deviations can seriously impact the integrity of clinical trials, and with regulatory scrutiny growing, it’s crucial to… 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
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
Blog21 August 2018 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,… Learn more
