Choosing your best route to DTx commercialization
In this guide, Castor discusses routes to digital therapeutics commercialization and tools to meet the challenges on the path to market
Navigating the DTx regulatory landscape
The regulations around digital therapeutics (DTx) are constantly changing. Learn how DTx providers are trying to overcome these challenges
Regulating digital therapeutic cybersecurity: today and tomorrow
Cybersecurity has become a concern for Digital Therapeutics (DTx) developers and regulatory bodies. Learn to balance functionality & security.
Overview of EU Medical Device Regulations
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 Readiness in 12 Countries
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.
Demystifying CDISC standards in the modern era of Decentralized Clinical Trials
Learn key compliance requirements, data collection tips, and important dates for the EU Medical Device Regulation in this white paper.
Post-Market Surveillance (PMS) for Medical Devices: What to Know & Do
Post-market surveillance (also known as Post-Marketing Surveillance or PMS) refers to the requirement that manufacturers monitor their medical…
Essential Guide to Post-Market Clinical Follow-Up (PMCF) for Medical Devices
Learn the full impact of PMCF under the EU MDR and how to best prepare your medical device studies.
PMCF & RWE: Roles of Medical Device Registry Studies & ePROs
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.