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Tag Archives: EN 62304

Requirements Engineering for Safety Critical Devices

by Siegfried Hörfarter, September 8, 2012, 
(220)

Software intensive hi-tech devices and systems more and more pervade our daily live. And it is not only in the area of road traffic, aviation or medical technology where an unintended and unplanned technical system behaviour might threaten the life and health of human beings.

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ISO 13485 Surveillance Audit successfully conducted

by Siegfried Hörfarter, May 28, 2012, 
(140)

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.

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