Medical Devices Quality Management Systems

Meet customer expectations, expand international markets

With technological advancements, more affluent living standards and an increasingly aging population, the medical profession is relying on devices they use like never before to save lives and to cure illnesses.

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.

Benefits of Certification

• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across the organisation
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that the organisation produce safer medical devices
• Meet regulatory requirements and customer expectations