By passing the demanding ISO 13485 certification test, Maxon Motors’ microdrives are good enough for implantation in humans.
Maxon Medical announced that it achieved in December an international certification that confirms the reliability of its microdrives.
The company which is based in Switzerland, is a division of Maxon Motors, a German company that specializes in the manufacture of electric motors and drives that are used in equipment with very tight tolerances. Maxon, which has major divisions in 13 countries, launched Maxon Medical in 2006 to focus specifically on supplying parts for the global medical-device market.
The certification, under the International Organization for Standardization’s 13485 requirement, is designed to provide a standardized way to verify that a company uses a comprehensive quality control and management system for the design and manufacture of medical devices. Requirements include not only quality control and consistency of design, but that parts made to be implanted are rigorously inspected and can be easily traced back to the manufacturer, as well as specific requirements for how the effectiveness of the device can be demonstrated.
– Kevin Fogarty