TÜV Süd Certification for All Diode Lasers

TÜV SÜD has been testing and certifying quality management systems for medical devices for over 30 years. This makes TÜV SÜD a market leader in countries with strict medical device regulations. Our products are certified to meet international standards, primarily ISO 13485.

ISO 13485 Standard

The international EN ISO 13485 standard is essential for market entry in many countries. It focuses on product safety and the effectiveness of implemented processes.

ECM – Ente Certificazione Macchine

ECM is authorized by the European Commission to issue EC certificates according to Directive 93/42/EEC (MDD). The CE Mark is mandatory for marketing and usage in the European Union.

EU Regulation 765/2008

The CE marking indicates compliance with the Machinery Directive and all other applicable EC directives. It serves as a passport for machines to be marketed and operated in the EU.

FDA 510 K

Food and Drug Administration (FDA) approval is required for distributing medical devices in the United States. Our quality management system complies with FDA regulation QSR 21CFR820.