The UK's draft International Reliance pathway would let device manufacturers build on approvals from trusted regulators such as FDA, TGA, and Health Canada to reach the Great Britain market faster. What's proposed, what's confirmed, and how to plan multi-market strategy.

The Medical Device Single Audit Program promises one audit that satisfies multiple regulators. How MDSAP works in 2026, what changed with QMSR and the program's new governance, and how quality teams can prepare for an audit designed to find more than a standard ISO 13485 certification would.