ISO 13485 is designed to demonstrate that medical device manufacturers, their design teams and sub-contractors follow a managed approach to all aspects of design, development and production with a strong focus on risk management and regulatory compliance.

The standard provides a base for compliance with the CE marking of medical devices for sale in Europe as well as requirements for other overseas markets, such as the US FDA design controls.

42T MD Howard Biddle said being awarded ISO 13485 is a significant development milestone and will be critical in helping build on our existing successes and track record in the medical devices and equipment market.