Management System Services

ISO 13485

Medical Devices — Quality Management Systems


ISO 13485 is a stand-alone QMS standard derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical devices manufacturing environment.

What it means for your business

Having ISO 13485 shows an established and maintained effectiveness of your process, while ensuring the consistent design, development, production, installation and delivery of medical devices that are safe for their intended purposes.


Companies that implement the requirements of ISO 13485:2016 and certification commonly find benefits such as meeting legal, regulatory, contractual and marketing requirements for proved product safety.

Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards.

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