ISO 13485:2016 - Medical Device Quality Management System (MDQMS)

ISO 13485 "Medical devices - Quality Management Systems" is the internationally recognised standard for quality management systems in the medical devices industry

ISO 13485 is aimed at organisations involved in the entire life-cycle of medical devices, from design to production and subsequent activities, including decommissioning and disposal. It also covers areas such as logistics, distribution, service, testing, calibration, sterilisation, etc., and can be used by organisations that produce raw materials, components and sub-assemblies.

The main objective of ISO 13485, in an industry that is highly regulated worldwide, is to promote global harmonisation of the requirements of regulations governing medical devices. Choosing to certify your system in accordance with this standard demonstrates your commitment to achieving continuous improvement and giving customers confidence in your ability to bring safe products to the market.

The Benefits of  ISO 13485:2016 Certification

ISO 13485 certification, which organisations can apply for regardless of their size, helps improve overall performance, eliminate uncertainty, manage risk (identified in relation to the safety and performance of the medical device for end-users) and extend market opportunities. Companies in possession of this certification demonstrate their commitment to quality to all stakeholders, whether end-users, customers or regulatory authorities.

Implementing and certifying a quality management system is a highly effective means of optimising resources and preventing and managing clinical risks and emergency situations. Certification enhances company image and consequently increases the confidence of users, by reassuring them that the medical device complies with the applicable safety and performance requirements. To sum up, an ISO 13485 certified management system helps organisations involved in any phase of the medical device life-cycle to:

• Demonstrate their compliance with mandatory requirements
• Implement good practices that consistently result in the supply of safe medical devices
• Manage risk effectively
• Improve processes
• Gain competitive advantage.