ISO 13485:2016 - Medical devices Quality management systems

ISO 13485:2016 defines requirements for regulatory purposes 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems.

All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization. It basically consists of: 1) certain ISO 9001 requirements and 2) newly defined requirements catering specifically to the medical device industry. As such, ISO13485 differs from ISO 9001 in certain ways, modifying or even excluding some of the latter's requirements.

Benefits of ISO 13485:2016 Certification

  • Recognition by regulators around the world of ISO 13485:2016 as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization’s image, culture and performance

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