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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 13485:2003 is the latest version of ISO 13485, 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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