Guide to eConsent Readiness in the US, Europe, and Israel
eConsent regulations vary widely across the world. Download this guide for an overview of the current regulatory situation in nine countries.
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.
Using Decentralized Trial Technology to Ensure Study Continuity and Data Quality During COVID-19 and Beyond
Download this white paper to learn why patient-centric, remote research technologies such as eConsent, EDC, and ePRO are critical during COVID-19 and beyond.
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…
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…
