Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software . In fact, every company focusing on medical device or pharmaceutical business

Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that a quality management system is able to ensure quality,

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