High quality standards

The CE mark, for example, proves that TRACOE medical devices are developed, manufactured and tested in compliance with the legally defined requirements and that they meet the basic requirements of the EC Medical Devices Directive 93/42/EEC (Annex 1). This is verified during regular audits by a notified body and confirmed with the issue of the CE certificate.

TRACOE products are registered and approved in numerous countries worldwide, including the USA (US 21 CFR 820) and Canada (CanMDR).

The QM certificate is proof of an effective quality management system in accordance with DIN EN ISO 13485. All TRACOE medical employees are integrated into this QM system, which guarantees the consistently high quality of all TRACOE products.