Medical Device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment, or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception

It does not achieve its principal 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;

Medical Device shall comply to CE mark directive before it is placed in the European Market. CE Mark means your products are conformed to EU Directive 93/42/EEC requirement.

The Quality Management System for Medical Device Manufacturer

ISO13485 Certification is the criteria to achieve CE Mark for Medical Device. ISO13485 is prepared by ISO (International Standard Organization) / TC210 Technical Committee Quality Management and Corresponding General Aspects for Medical Devices.

For more details, pls click into ISO13485 and Medical Device Directive 93/42/EEC