The Information Security Management System Policy is one of the ket document for an efficient management of information security and to reach adequate level of compliance against ISO 27001. We

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

ISO 13485 FDA ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we want to discuss about the future integration between ISO