Post-Market Clinical Follow-Up (PMCF)

Registry studies focused on a specific medical device are a valuable tool to capture the safety and outcomes of the device over its lifetime. Read more here.

Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this white paper.

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

Under the MDR, PMCF activities will be mandated as part of medical device surveillance programs. These activities should…

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.

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…

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

To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance…