Quality Management

Our Commitment to Quality

MLase is a medical device manufacturer with a certified quality management system compliant with EISO 13485/ EN ISO 13485. We develop and manufacture our products with the highest standards of performance and quality – in pursuit of reliability and safety for patients.

Quality at the Core of MLase

At MLase, quality is the foundation of everything we do. We design, develop, and manufacture medical devices and laser systems with the highest standards to ensure patient safety and reliable performance.

We operate a certified quality management system compliant with ISO 13485/ EN ISO 13485. This certification covers development, production, sales, and service of excimer laser devices and laser sources, as well as contract manufacturing of active therapeutic medical devices.

Products are developed and manufactured under strict quality controls. Every step – from design to production – follows rigorous procedures to guarantee reliability and safety.

ISO 13485

Certified quality management

Development, production, sales and service of excimer laser devices and excimer laser sources for integration into medical laser systems as well as contract manufacturing of active therapeutic medical devices.

TÜV Rheinland
Zertifikat
Deutsch
Qualitätsmanagementsystem EN ISO 13485
Registrier-Nr.: SX 2551152-1
Gültig bis: 19.11.2028
Certificate
English
Quality Management System EN ISO 13485
Registration No.: SX 2551152-1
Expiry date: 2028-11-19

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