Medical Device Regulation (MDR)

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

The world may have changed seemingly overnight, but clinical research and medical innovation must continue now more than…

A recent report surveying representatives from the medical device industry across the world found that more than 55%…

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…

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…