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Quality

Contec is a competent HIGH-TECH provider with a distinct and comprehensive quality awareness. The high demands we place on all divisions of our firm is audited continuously by an active quality management system.

 

As a long-term manufacturer of medical technology CONTEC guarantees for its excellent quality. We have the necessary experience to the appropriate documentation required under the EU directive for medical devices (93/42/EEC).

 

From the outset, this QM system was establishes on the basis of a modern process-oriented approach and continues accordingly. Our company is certified by the German DEKRA organisation as per EN ISO 9001 / Rev. 2003 and according to the medical equipment standard EN ISO 13485 / Rev. 2003.

 

In particular, medical equipment companies are subject to very stringent inspections. With certification according to ISO 13485, we are better able to serve these companies.

 

Furhtermore, several of our products as well as products of our customers have received international product approvals such as UL, CSA and NRTL, thus we are routinely audited by these organizations (TÜV and UL).

 

We meet the applicable requirements of CMdR (Canadian Medical Device Regulation) while meeting the CMDCAS (Canadian Medical Device Assessment System).

 

We will gladly send you a list of our satisfied customers upon request.