Author: Mariacarey

these steps, manufacturers of IVD devices can navigate the complexities of the EU medical device registration process and achieve MDR compliance. Partnering with regulatory experts and consulting firms like Cliniexperts... Read More

Comprehensive documentation is crucial for MDR compliance, enabling transparency, traceability, and accountability throughout the medical device lifecycle. Rigorous documentation of design, risk management, clinical evaluations, manufacturing, and post-market surveillance demonstrates... Read More