Resource Library

Download this white paper to prepare for the new MDR requirements requiring that PMCF investigations be conducted in compliance with ISO 14155.

Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR requirements.

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.

July 17th 2020: This document has been updated to reflect regulatory changes in response to COVID-19. As this…

With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for…

2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul…

Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with…

Introduction The implementation of the new EU Medical Device Regulation (MDR) just got a plot twist: COVID-19. This…

Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As…

As of early April 2020, over 1,000,000 people have been confirmed infected with the SARS-CoV-2 coronavirus, and governments…