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 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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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”?