Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software .…
What is ISO 13485 quality management system
Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that…
ISO 13485 and the FDA : The Future of Quality Management Systems
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we…