Design History File (DHF): An Overview
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation…
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…
Statistic for Quality Management Systems: ISO and FDA Requirements
The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and…