The PMCF - Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements related post-market clinical follow-up plan and report have been further

The ISO 45001 is a standard related to the management of occupational health and safety; here we provided an overview of ISO 45001 clauses, requirements, a list of documentation requested

FMEA (Failure Mode Effect Analysis) is definitely the most widely used method for assessment of risks associated two any type of devices and processes. This is valid for any type

Due to Brexit, UK will not recognised CE mark for medical devices and an UKCA mark and the related UKCA conformity assessment will be mandatory to place medical devices in

Combination products will undergo to a substantial change under the EU MDR 2017/745 and new regulatory challenges are at the horizon. Drug-device combinations (DDC) became an essential tool for