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ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe.

ISO 13485 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices and calls for:

  • Implementation of a Quality Management System with several enhancements

  • Risk Management approach to product development and product realisation

  •  Validation of processes

  • Compliance with statutory and regulatory requirements

  • Effective product traceability and recall systems

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