ISO 13485 – Medical Devices Management System (MDQMS)
ISO 13485 is an international standard that sets out requirements for a comprehensive management system for the design, development, manufacture, installation and servicing of medical devices. This system is essential for any organization operating at any tier in the medical device supply chain. Now a days, it is often a common requirements towards European, Canadian and other regulatory requirements for medical device manufacturers.
Benefits of ISO 13485 Certification
When an organization implement ISO 13485 effectively, it will gain tangible benefits. Some benefits are given:
Improved risk management and quality assurance
Meeting customer expectations and improved ability to respond to customer requirements
Increased efficiency and cost savings
Improved ability to win more business through proven business credentials
Help to maintain the quality of supply chain
