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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, MDR Rudiger Mees Regulatory, MDR Rudiger Mees

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 stops accepting CE marking? The UKCA transition is closer than most compliance teams realise.

Can a single risk management file really travel across six jurisdictions? ISO 14971 might be the most underrated tool in global DHT compliance.

Why did a CE-marked wearable delay an oncology trial by six months? The answer involves three letters: IDE.

Is your DHT compliance plan actually a European compliance plan with a global-sized blind spot? Time to find out.

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