Regulations

This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote interactions in their clinical studies.

This playbook is a tool for sponsors and CROs who want to leverage DCT technology to support remote interactions in their clinical studies.

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.

The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the…

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…

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