eConsent – The Enrollment Solution for Decentralized Trials
Join this webinar to understand how eConsent works, where it falls in the regulatory guidelines & see a practical demonstration of eConsent software.
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.
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.
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.
In-Vitro Diagnostic Regulation (IVDR): From oversight to overhead
The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the…
An Expert Panel on Decentralized and Hybrid Trials, Pre and Post COVID-19
The world may have changed seemingly overnight, but clinical research and medical innovation must continue now more than…
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…