Global Artificial Intelligence Rules Are Coming Fast And Out Of Sync
A breakthrough AI diagnostic passes FDA review but triggers high-risk classification in Europe. The same algorithm, trained on global datasets, is rejected by China's regulators. As AI medical device rules fracture across borders, SaMD startups discover that regulatory approval in one market guarantees nothing elsewhere.
Your "Finished" Regulatory Submission Is Actually Just Getting Started
Submission timelines don’t stop at approval. When regulatory frameworks shift mid-cycle or rationale documents vanish with a departing team member, what’s left behind is risk. Discover how MedTech startups can design regulatory systems that adapt, retain context, and strengthen every future interaction with regulators.