Insights on DHT compliance
EU MDR, FDA DHT guidance, EUDAMED, data integrity and the operational reality of digital health in clinical trials.
BYOD/eCOA in 2026: Timestamp Drift, Part 11/GDPR, and Audit Trails No One Wants to Own
What is “timestamp drift,” and how can a few minutes of clock deviation invalidate your eCOA endpoint data? Who actually owns the audit trail when…
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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…
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The Global Compliance Map: Deploying DHTs Across Borders (Part 7/8)
Are your DHTs classified and registered in every country where they’re used? Have you appointed local importers and authorised representatives? Do your…
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Roles Redefined: Manufacturer, Importer, System Producer — Which Are You? (Part 6/8)
Are you certain your organisation’s role under MDR or FDA law is correctly defined? Have you appointed authorised importers or representatives for DHT…
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ALCOA++ in the Age of Digital Health Technologies (Part 5/8)
Can your audit trail reconstruct every DHT data transformation from source to submission? Are firmware, algorithms, and databases synchronised under one…
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Endpoints and Algorithms: How Firmware Can Break Your Study (Part 4/8)
Can a single firmware update, algorithm change or data-sync failure invalidate months of trial data? How did the FDA’s DHT guidances change who answers for endpoint traceability and version control?
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Quality-by-Design for DCTs: Turning FDA’s DHT Framework Into an Inspection-Ready Reality
Could your digital endpoints survive if an FDA inspector asked you to “show how this was generated”? Are your device, algorithm, and data teams aligned—or…
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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…
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Validation of Clinical Trial–Related Systems in Smaller Enterprises: Challenges and Practical Tips
How can small companies overcome the challenges of validating clinical trial systems on tight budgets? What are the risks of not validating clinical trial…
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Ensuring a Validated State in Life Sciences Companies: A Q&A with Validation Itself
What does “validation” really mean in the Life Sciences industry, and why is it critical to success? Could skipping validation lead to costly recalls or…
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Navigating AI Regulations: Insights on FDA’s AI/ML Guidance and the EU AI Act
How do the FDA's AI/ML guidance and the EU AI Act differ in regulating AI in life sciences? What challenges do life sciences companies face when complying…
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Ensuring Data Integrity in Medical Device and Pharma Companies: A Key to Compliance and Patient Safety
Could your company’s data integrity withstand an FDA inspection? What do the ALCOA+ principles require of medical device and pharma records in practice, and which controls make them hold up?
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