Regulations

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

Medical device regulations in the EU have recently undergone a major overhaul. Learn the key tenets of MDR by device classification in this fact sheet, and what checklist items must be addressed to be fully compliant.

eConsent is imperative for continuing research during the COVID-19 pandemic and beyond, but regulations can vary widely across borders. Download this whitepaper to learn the regulatory stances of 12 countries on the use of eSignature and eConsent in clinical trials.

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

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

Learn the full impact of PMCF under the EU MDR and how to best prepare your medical device studies.

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.

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

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…