TRACOE medical products are CE-certified. This documents the fact, that they are developed, manufactured and tested in compliance with legal requirements and the basic stipulations of the EC directive on medical products 93/42/EEC (Annex 1).
This certification is regularly renewed on the basis of audits by a designated institution. QM certification has also been obtained to show that TRACOE medical has implemented an effective quality management system which conforms to DIN EN ISO 13485:2012AC 2012. All of TRACOE medical’s staff are integrated in this quality system to ensure a consistently high level of quality for all TRACOE products.
In close consultation with the customers new products are developed, product variants – within technical possibilities – are produced and the existing products are improved. Thus the high standard of quality is further optimized. TRACOE products meet the requirements of the most demanding applications and comply with all relevant national and international guidelines and standards. They are registered and approved in many countries worldwide, including the United States (US21CFR 820) and Canada (CanMDR).