ISO 14971
Risk management across the device lifecycle: hazard identification, risk control, and the residual risk you accepted on the record before release. It is not a document written once — every firmware release, OS update and retrained model reopens it for the device that changed.
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 →Medical Device Software Development — service brochure
Medical device software development, from planning and requirements through risk management (ISO 14971), development and verification.
Open the paper →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…
Read the article →Are Consumer Devices (e.g. Fitbits, …) Compliant for Endpoint Data Collection?
Can consumer wearables like Fitbits generate regulatory-grade clinical trial data? What risks arise when sponsors use consumer devices for endpoint…
Read the article →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 →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?
Read the article →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.
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 →From Concept to Market: Best Practices for Developing Compliant Safety-Critical Medical Software
What are the essential regulatory requirements for developing safety-critical medical software? How can a robust quality management system enhance compliance…
Read the article →How to Survive – and Win – in the New Digital Health Economy (Part 8/8)
Is your organisation’s QMS built to manage devices, data, and endpoints together? Would your DHT-derived evidence survive a multi-country audit? Who in your…
Read the article →Navigating CE Marking and Global Compliance for DHTs in Clinical Trials
Does your CE mark actually protect you outside the EU? Most sponsors assume it does — until their US arm hits an IDE requirement. What happens when the MHRA…
Read the article →Reverse Logistics: Recovering DHTs Without Breaking Data Chains
How can sponsors eliminate “data breaks” across global DHT logistics networks? What are regulators expecting in traceability documentation under MDR and GCP?…
Read the article →Risk-Based Quality Management (RBQM) in the Medical Device Industry: Strategies for Effective Implementation
Are you focusing your quality efforts on the right areas, or are you spreading resources too thin? How can risk-based quality management streamline your…
Read the article →Sponsor Oversight of Digital Health Technologies in Decentralised Clinical Trials: A Regulatory Guide
How do sponsors avoid becoming “accidental manufacturers” when deploying wearables in trials? What happens if a consumer-grade DHT fails to meet regulatory…
Read the article →The 2024 FDA DCT Guidance Decoded: 9 Operational Traps Sponsors Still Fall Into
What hidden operational traps are still tripping sponsors under the 2024 FDA DCT guidance? How can sponsors maintain investigator oversight across…
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?…
Read the article →When a Digital Health Tool Becomes a Medical Device: The Hidden Regulatory Roles No One Told You About
If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device? Who’s carrying the…
Read the article →“It’s Just a Phone”
Did you know a consumer smartphone can trigger four separate regulatory frameworks the moment it touches a clinical endpoint? Why do so many sponsors fail…
Read the article →A document appears here because it names ISO 14971 in its own text. Nothing is inferred: this is what we have actually written about it.