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 implementation of an active quality management system.
As longtime manufacturer in the medical technical sector, CONTEC vouches for its excellent quality management. In addition, we have the necessary experience in the documentation required by the EU regulations for medical products (93/42/EWG).
From the outset, this QM system was established on the basis of a modern process-oriented approach and continues accordingly. The company is certified according to EN ISO 9001:2000 and according to the medical equipment standard EN ISO 13485:2003/AC2007 by the German DEKRA organization.
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.
Furthermore, 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 fulfill the applicable requirements of the CMDR (Canadian Medical Device Regulation) in compliance with CMDCAS (Canadian Medical Device Assessment System).
We will gladly send you a list of our satisfied customers upon request.
