Insights on DHT compliance
EU MDR, FDA DHT guidance, EUDAMED, data integrity and the operational reality of digital health in clinical trials.
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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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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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.
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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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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…
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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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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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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.
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A Lean Approach to Digital Risk, Quality, and Compliance Management for Small to Medium Life Sciences Companies
How can small to medium-sized life sciences companies effectively manage compliance without large budgets? What strategies can SMEs employ to navigate…
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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…
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AI Software Assurance Framework for FDA-regulated applications
How does the AI Software Assurance Framework ensure compliance in FDA-regulated applications? What are the key components of an effective AI Software…
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The ROI of Seeking External Advice for Medical Device Companies: Why Expert Support is a Smart Investment
How can seeking external expert advice accelerate your medical device’s time to market? What is the ROI of engaging external consultants for your medical…
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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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Walking the Compliance Tightrope: The Risks and Challenges of Being the PRRC in the Medical Device Industry
What are the primary responsibilities of a Person Responsible for Regulatory Compliance (PRRC) in the medical device industry? How does the PRRC ensure…
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