The Regulatory Status Quo Is Dead (And Artificial Intelligence Killed It)
MedTech regulatory teams are shifting from document-heavy workflows to AI-powered predictive systems in 2025. Modular content libraries, structured claims management, and machine learning transform MLR reviews while reducing submission timelines. Traditional static approaches create bottlenecks as patent cliffs drive faster launches across multiple jurisdictions.
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.