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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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 organization owns responsibility for device version control?
Would your DHT endpoints withstand an ALCOA++ traceability audit?
Have you mapped classification and importer roles for every deployment country?
Does your QMS integrate ISO 13485 and 14971 for device-level oversight?
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 duplication?
What are the must-have elements of a DHT-ready quality system?
How are CROs redefining quality roles in decentralized, device-enabled studies?
Could a missing DHT process in your QMS create inspection exposure?
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 legal liability for your connected device right now—the manufacturer, the sponsor, or… you?
When your next trial audit lands, will your documentation prove compliance—or just prove confusion?
How confident are you that your “wellness app” wouldn’t trigger MDR or FDA oversight if used tomorrow in a global study?
While others are quietly securing their regulatory status, are you still assuming “we’re not a medical device company”?