ISO 13485 : 2016 is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry’s quality system expectations and regulatory requirements, an organisation does not need to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485 : 2016 applies to design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet customer and legal requirements.

ISO 13485 Benefits

  • Increased access to more markets worldwide with certification

  • Outline how to review and improve processes across your organisation

  • Increase efficiency, cut costs and monitor supply chain performance

  • Demonstrate that you produce safer and more effective medical devices

  • Meet regulatory requirements and customer expectations