IEC 62366-1
Usability engineering: use error, human factors, and validation with the population that will actually hold the device. These are the manufacturer’s obligations. A sponsor recruiting elderly or paediatric participants carries its own duty through fitness for purpose and GCP: checking that a vendor’s validation in healthy adults actually covers the people in the trial.
DeviceFit — fit-for-purpose validation
Technical, clinical and operational validation aligned to ISO 14971, IEC 62366-1, FDA QSR, EU MDR Annex I and ICH-GCP.
Open the paper →Best Practices for Usability Testing in DHTs
What makes usability testing a regulatory requirement for DHTs? How can poor usability compromise data integrity in decentralised trials? What are the most…
Read the article →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 the article →Device Fit and Classification: When “Commercial” Becomes “Clinical” (Part 3/8)
Have you validated every DHT used in your trial for analytical, clinical, and usability accuracy? Are you certain of each device’s risk class in all…
Read the article →Fit-for-Purpose or Bust: A Real-World Rubric for DHT Verification, Validation & Usability
What makes a DHT truly “fit-for-purpose” in a clinical trial context? How do verification and validation differ—and why does it matter? What role does…
Read the article →From Compliance Burden to Competitive Edge: How DHT Readiness Can Shorten the Path Through Review
Can building DHT compliance into trial design, rather than adding it later, mean fewer regulator questions and less rework? Is your compliance programme adding time to your timelines—or saving it?
Read the article →The DHT Compliance Wake-Up Call: Why “Digital-Ready” Isn’t “Regulator-Ready” Anymore
Could you reconstruct any digital endpoint in your trial for an inspector—without opening PowerPoint? Is your DHT compliance actually regulator-ready, or…
Read the article →The DHT-Ready QMS: Integrating Device, Data, and Clinical Quality into One System (Part 2/8)
Does your QMS include design-history and validation records for every DHT you use? Are firmware, algorithms, and human-factors results governed under change…
Read the article →The Shockwave: What the FDA’s DHT Framework Really Means (Part 1/8)
Are your current DHTs validated for analytical, clinical, and usability accuracy? Who in your organisation owns responsibility for device version control?…
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