LIBRARY

It examines the most common non-conformities identified by Notified Bodies during audits and assessments, offering practical solutions to prevent and effectively manage them.

From EU regulation (MDR/IVDR) to the specific Italian Guidelines of 2025: this white paper covers the fundamental principles and rules [...]

This white paper summarizes the key contents and highlights from the morning roundtables of MDG 2025 – MedGenerAction which took place in Bologna on October 1st, 2025. MDG is the annual reference summit for professionals operating in the Medical Device sector, presented by Complife Group.

This white paper provides an overview of the basic concepts and requirements of the Post-Market Surveillance System (PMS) in the [...]

This white paper brings together some of the key information presented and discussed in the morning session of the MDG [...]

This White Paper is a concise and practical guide to the classification of Medical Devices in the United States, with a [...]

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 [...]