Medical Devices

ISO 13485:2016 specifies requirements for a Quality Management System for medical devices.  In compliance with this standard, 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 is also applicable to suppliers or external parties that provide product, including quality management system-related services to such organizations.

QualityAdvantage provides all the expertise and support needed to implement, maintain and improve an ISO 13485 certified and/or 21 CFR 820 compliant Quality Management System (QMS), including

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