Providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.Investigation, replacement, modification, or support of the anatomy or of a physiological process,.Diagnosis, monitoring, treatment, alleviation of or compensation for an injury,.Diagnosis, prevention, monitoring, treatment or alleviation of disease,.The ISO 13485 standard contains specific requirements for manufacture, installation and servicing and requires ISO 13485 also can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements. Having certification demonstrates your commitment to meeting your customer requirements.

The ISO 13485 standard for medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets.

While this is a stand-alone standard, it is based on ISO 9001. ISO 13485 standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

EN iSO 13485 MEDDEV 2.7.1