Welcome to our blog, your go-to resource for the latest insights and trends in the life sciences industry.

Our blog is designed to provide expert guidance, practical tips, and thought leadership on key areas like medical device development, digital health, and clinical trial optimization. We cover a wide range of topics, including decentralized clinical trials (DCTs), the integration of digital health technologies (DHTs) in DCTs, and the use of Platform as a Service (PaaS) in medical device software development, to help you navigate the complex intersection of innovation and regulation. Our goal is to keep you informed and equipped with the knowledge needed to overcome industry challenges, drive innovation, and succeed in the rapidly advancing life sciences sector. Explore our blog for in-depth insights and the latest developments, and feel free to reach out if you need further assistance.

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Regulatory Rudiger Mees Regulatory Rudiger Mees

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 just conference-ready?

Do you know who owns algorithm governance in your organisation—or is that question still a shrug?

When was the last time you mapped device classification, import rules, and data residency for every country in your trial?

What happens to your digital endpoints when your vendor pushes a firmware update you never assessed?

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