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.
The Regulatory Guidance Maze That's Quietly Strangling MedTech Growth
Fragmented folders and outdated tools are hindering regulatory teams' efficiency. MedTech leaders are changing the game by implementing structured intelligence systems to minimize submission delays, lower compliance risks, and transform guidance overload into a growth strategy. Here’s how the top performers are gaining an advantage.