How an Unregulated IoT Platform Increases Your Risk and Delays Time to Market

Challenges with digital health regulation

There is significant ambiguity surrounding the digital health regulatory landscape today. It’s a topic of growing concern as more and more biopharma and medtech companies are developing Digital Therapeutics, Software as a Medical Device (SaMD), connected combination products, companion apps and more.

To address the burning questions that digital health execs are struggling to answer, BrightInsight spoke with industry experts – from biopharma execs to partners at law firms who advise companies on how to approach their regulatory strategy.

Download our white paper to learn about:

• Digital health regulatory trends in the United States and Europe
• The difference between GxP-compliant, Medical Device Data Systems and regulated software platforms
• How to determine whether or not you need a regulated infrastructure
• Why it’s important to contemplate your regulatory strategy for your digital health products now — and in the future