Unit 12 of 17

Approved to Sell — and Stay Sold

How an implant earns the right to be sold and keeps it: US classes and the 510(k), EU classes and the CE route, predicates, change decisions, UDI, reading any country’s system, staying sold and honest claims. Then answer an FDA inspector about a plate variant.

8 hands-on lessons, then a case · about 30–45 minutes