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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FDA’s Final Guidance on Cybersecurity in Medical Devices: Insights and a Comparison with EU Frameworks
What the FDA’s 2023 final guidance on cybersecurity in medical devices asks of manufacturers — security risk management within the quality system and the content of premarket submissions — and how it compares with the EU frameworks.
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The Evolution of Telemedicine and Its Impact on Medical Device Innovation
How is the rise of telemedicine reshaping the landscape of medical device innovation? What new opportunities does telemedicine present for developing…
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The Importance of Cybersecurity in Medical Device Manufacturing: Safeguarding Patient Data and Ensuring Regulatory Compliance
How can robust cybersecurity measures safeguard patient data in medical device manufacturing? Are your medical devices protected from cyberattacks that could…
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