Using AI to Interpret Lab Results? Here’s When It Becomes a Regulated Medical Device
AI is transforming how biotech and longevity companies interpret biomarkers, blood panels, and genomics — but the moment your AI starts informing diagnosis or clinical decisions, it becomes a regulated medical device. This guide breaks down the regulatory line, FDA/MDR implications, PCCP, cybersecurity requirements, and how to build compliant AI systems without slowing innovation.
Kristina Romanenko
2 days ago7 min read