ISO 13485:2016 is an independent quality management system (QMS) standard based on the globally acknowledged ISO 9000 series for quality management. It customizes the ISO 9000 process-oriented model to suit the controlled environment of medical device production.
What it means for your business
Having ISO 13485:2016 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 achieve certification commonly find benefits such as:
Meeting legal, regulatory, contractual and marketing requirements for improved product safety.
Although not fully harmonized, an ISO 13485:2016 Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards.
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