eBook: The Decentralized Clinical Trial Playbook
This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote interactions in their clinical studies.
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.
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.
6 essential steps to ensure MDR compliance before May 2021
A recent report surveying representatives from the medical device industry across the world found that more than 55%…
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.
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…