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ISO 13485 Certification

The measure of all things for medical devices: Safety

ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for organizations involved in one or more stages of the life-cycle of a medical device and describes a process approach in terms of the design, safety and quality.

ISO 13485 is based on the structure of ISO 9001, but it also includes industry-specific requirements for the medical device sector. The standard is harmonized with the applicable EU directives 93/42/EEC (for medical devices) and 98/79/EC (for in-vitro diagnostic devices).
Certification according to ISO 13485 helps demonstrate compliance with relevant regulations in the manufacture of medical devices and ensures that all important industry requirements are met. It therefore facilitates access to new markets and the acquisition of new customers.