Insights on DHT compliance
EU MDR, FDA DHT guidance, EUDAMED, data integrity and the operational reality of digital health in clinical trials.
AllFDA28Wearables and sensors23Data integrity21EU MDR & IVDR20Digital endpoints17AI and machine learning15Risk management15Validation12ICH E6(R3)10Decentralised trials6Cybersecurity4Market & strategy4Inspection readiness3Vendor oversight3Change control2Economic operators2BYOD1Data protection1Interoperability1Software & SaMD1
3 articles tagged “Vendor oversight”
28 Oct 2025
DHT QMS: The Missing Link Between Mature Systems and Digital Health Readiness
Is your QMS framework prepared to manage device-level risk and traceability? How can sponsors extend quality oversight to digital endpoints without…
Read article →
21 Jul 2025
ICH GCP E6 (R3): When Digital Health Became Everyone’s Responsibility
For years, Digital Health Technologies sat in an awkward middle ground in clinical trials. Sponsors relied on them but didn’t always own them.
Read article →
3 Feb 2025
ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Centre
For years, Digital Health Technologies lived slightly outside the GCP spotlight. Useful? Yes. Innovative? Absolutely. GCP-critical? Not always. ICH GCP E6 (R3) changes that.
Read article →