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ISO 13485:2016, Medical devices - Quality management systems – Requirements for regulatory purposes 08 Aug

ISO 13485:2016 Medical Devices – Quality management systems

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What is ISO 13485?

ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers of medical devices and equipment. The main objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical devices sector.

Key benefits of ISO 13485

  • Meet regulatory requirements
  • Demonstrate that medical devices are produced safely
  • Increase device sales by accessing more markets.

How is ISO 13485 structured?

ISO 13485 has been based on the requirements of ISO 9001 and has the same structure in terms of clauses. The ISO 13485 standard, medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets. Having certification demonstrates your commitment to meeting your customer requirements.

Who can apply for ISO 13485 certification?

ISO 13485 is applicable to all manufacturers and suppliers of medical devices, components, contract services and distributors of medical devices. For a number of markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices.

Requirements of the ISO 13485 standard

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing and requires:

  • Risk management approach to product development and product realisation
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems
  • Implementation of a quality management system with several enhancements.

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