21 CFR 820 : Overview of the Main Requirements
The part of the Code of Federal regulation 21 CFR Part 820 is the section related to the requirements for Quality Management System of medical device manufacturers that want to
The part of the Code of Federal regulation 21 CFR Part 820 is the section related to the requirements for Quality Management System of medical device manufacturers that want to
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016. We have already been
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation of the design history file (DHF) for medical devices according to