With our Embedded Systems business we have successfully conducted the ISO 13485 surveillance audit. We are already holding the ISO 13485 certification since April 2010.
The ISO Standard defines the regulatory quality management requirements for design and production of medical devices and products. The surveillance audit must be performed on a regular base every year; and our next Re-Certification is planned in 2013.
The surveillance audit was performed by assessing two projects: One of them is a medical ventilator system for intensive care medicine. The other one is a very compact system comprehensively used in the emergency medicine domain.
Again, we are very happy with the results and findings of the auditor. Our medical engineering process definition and process application in the projects is best rated and we are well prepared for the further growth in medical industry.
In combination with EN 62304 and ISO 14971 the ISO 13485 is important for us to support our specialised Smart Products Engineering offerings with Embedded Hard- & Software Development as a one stop service. Ergonomically optimized HMIs and intelligent Connectivity & Telemedicine solutions enable a new category of smart devices and applications for our Medical industry customers.