White papers & guides14 October 2020 Guide to using Electronic Data Capture (EDC) for Medical Device & Diagnostics Trials Download this guide to learn how to incorporating an Electronic Data Capture (EDC) system in your medical or diagnostics device trials. Learn more
White papers & guides18 August 2020 The Impact of ISO 14155 on PMCF Investigations Under the MDR Download this white paper to prepare for the new MDR requirements requiring that PMCF investigations be conducted in compliance with ISO 14155. Learn more
White papers & guides30 June 2020 5 steps to meet PMCF requirements Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR requirements. Learn more
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
Blog articles28 April 2020 The 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
Blog articles24 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
