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ISO 13485 : Quality Management System for Medical Devices

ISO 13485 is the international standard recognized for medical device regulations around the world.

It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

ISO 13485 standard published in July 2003. This standard is based on the ISO 9001:2000 process model approach. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation.

  • Manufacturers of high-risk medical products must be associated with a notified body to vouch for the product's quality. This is achieved through product testing and auditing of the manufacturer's quality management system.
  • Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective.
  • Adoption of this standard assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations

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