Regulations

Cybersecurity has become a concern for Digital Therapeutics (DTx) developers and regulatory bodies. Learn to balance functionality & security.

In today’s rapidly evolving regulatory landscape, ensuring medical device safety and performance goes beyond the approval phase. Effective…

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.

COVID-19 changed the conversation around enrollment and recruitment for clinical trials. Learn how eConsent is helping researchers do more despite restrictions.

In September 2020, Castor CEO Derk Arts, MD, Ph.D., led a webinar on electronic informed consent (eConsent) challenges…

In the wake of Brexit, medical device companies secure a UKCA mark as proof of conformity to place their device on the UK market. Learn what this means for your organization and how to prepare.

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…