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ISO 13485:2012


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ISO 13485:2012

The ISO 13485:2012 is an international standard for Quality Management Systems designed for the manufacturing of medical devices. It can also be used for the development production, installation and servicing of medical devices. Main aim of ISO 13485:2012 is to harmonize the medical device regulatory requirements and to enhance the credibility of an organization with potential customers.

ISO 13485:2012 results in increased efficiency, quality and improved customer services for the requirements of a quality management system. ISO 13485:2012 can help an organization to express its ability to provide medical devices; related services and commitment to quality that continuously meet customer requirements and regulatory requirements applicable to medical devices.

Advantages of ISO 13485:2012 Certification

  • Customer satisfaction
  • Reduces operating costs
  • Improved stakeholder relationships
  • Legal compliance
  • Improved risk management
  • Proven business credentials
  • Ability to win more business