The internationally recognized quality management standard for organizations involved in the design, production, and servicing of medical devices.
ISO 13485 sets out requirements for a Quality Management System specific to the medical device industry — covering design and development, production, installation, and servicing, with an emphasis on regulatory compliance and risk management across the product lifecycle.
It's closely aligned with regulatory requirements in many markets, making it a common step toward regulatory approval for medical device manufacturers.
Manufacturers, suppliers, and service providers involved anywhere in the medical device lifecycle — design, production, distribution, installation, or servicing.
Aligns closely with requirements in multiple markets.
Risk is managed from design through to servicing.
Clear tracking of components and processes throughout.
A recognized mark of quality for clinical and regulatory partners.
The standard most medical device buyers expect to see.
Smooths the path into new international medical markets.
The same straightforward path applies across every standard we certify.
Gap review & scoping
Build your management system
Stage 1 & Stage 2 audit
Certificate issued
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