ISO 13485: 2016 Medical Devices

ISO 13485 : 2016 Medical Devices – Quality Management Systems

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organizations 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 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

What does the 2016 revision bring to the medical device industry?

  • Alignment of global regulatory requirements.
  • Inclusion of risk management and risk-based decision making throughout the Quality Management System
  • Additional requirements and clarity with regard to validation, verification and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • More explicit requirements for software validation for different applications


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