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 (93/42/EC).

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 and performance.