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ISO 13485 – Medical Devices – Quality Management System:


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

 

It is intended to promote harmonization 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 organizations 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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