LIBRARY

Thanks to the MDSAP (Medical Device Single Audit Programme), it is possible to access multiple markets with a single audit. This [...]

This white paper discusses the topic of artificial intelligence, giving definitions, describing its main applications in general, focusing on those [...]

This White Paper provides a comprehensive overview of the marketing of Medical Devices in the USA, focusing on device classification, [...]

This White Paper provides the necessary definitions and requirements for borderline devices, in particular for substance-based devices including a medicinal [...]

This whitepaper describes the obligations and responsibilities of the Swiss Authorised Representative (CH REP), roles required by Swiss regulations to market [...]

This Whitepaper provides information and practical tips for the proper management of Critical Suppliers by MDR (EU) 2017/745 and IVDR [...]

In this Whitepaper you will find the answers to some of the most common Deficiencies issued during MDR (EU) 2017/745 [...]

The Regulatory Affairs Professional in the medical field plays a significant and decisive role throughout the device’s lifecycle. In this [...]

This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the [...]