new ISO 9001 :2000 certification
(September 28th 2001)
Debiotech announces that it has recieved ISO 9001
:2000 as well as EN ISO 13485 :2000 certification from :
- SQS, the Swiss association for quality and management systems
of Zollikofen in Switzerland.
- TüV product Service of Munich in Germany.
The latter is a notified body under the European Medical Directive
Already in 1995, Debiotech was among the first
medical device manufacturers to acquire certification to ISO 9001,
EN 46001 and the MDD's Annex II. The recent enhancement to the new
international ISO 9001 :2000 and ISO 13485 standards demonstrates
Debiotech's commitment to quality and assures that the devices it
designs meet international requirements for safety, effectiveness