eBooks

Regulatory Strategy as a Competitive Advantage

2023 Regulatory performance report

Post-market surveillance for medical devices in the European Union

CE marking guide for medical devices in the EU

The beginner's guide to the FDA PMA submission process

The beginner's guide to the FDA De Novo classification process

The ultimate guide to the medical device single audit program (MDSAP)

The ultimate guide to the China UDI system and database

The beginner's guide to the FDA 510(k)

The RIM buyer's guide for medtech companies

The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)

The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System