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Resource Library

eBooks

A Guide to MedTech RIM Maturity for a Successful Modernization Strategy
EBOOK
A Guide to MedTech RIM Maturity for a Successful Modernization Strategy
Regulatory Strategy as a Competitive Advantage
EBOOK
Regulatory Strategy as a Competitive Advantage
2023 Regulatory performance report
EBOOK
2023 Regulatory performance report
Post-market surveillance for medical devices in the European Union
EBOOK
Post-market surveillance for medical devices in the European Union
CE marking guide for medical devices in the EU
EBOOK
CE marking guide for medical devices in the EU
The beginner's guide to the FDA PMA submission process
EBOOK
The beginner's guide to the FDA PMA submission process
The beginner's guide to the FDA De Novo classification process
EBOOK
The beginner's guide to the FDA De Novo classification process
The ultimate guide to the medical device single audit program (MDSAP)
EBOOK
The ultimate guide to the medical device single audit program (MDSAP)
The ultimate guide to the China UDI system and database
EBOOK
The ultimate guide to the China UDI system and database
The beginner's guide to the FDA 510(k)
EBOOK
The beginner's guide to the FDA 510(k)
The RIM buyer's guide for medtech companies
EBOOK
The RIM buyer's guide for medtech companies
The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)
EBOOK
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
EBOOK
The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System