ISO 13485 Medical Devices Management System
What are the benefits to your business in implementing ISO 13485?
- 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
What is ISO 13485 Medical Devices Management System?
ISO 13485 is an internationally recognised standard that sets out requirements for a comprehensive management system for the design, development, manufacture, installation and servicing of medical devices. It is often seen as the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers. This system is essential for any organisation operating at any tier in the medical device supply chain.
Implementing this system means not only increased efficiency and cost savings but the improved ability to win more business through proven credentials.