Quality policy

Highest standards & Quality products

We are committed to provide the highest standard quality products and services that will meet or exceed our customers’ expectations, comply with regulatory requirements, and to maintain the effectiveness of the Quality Management System.

The company fully complies with international regulatory requirements. With our comprehensive, highly efficient quality management system, Lithotech fully complies with EU requirements and regulations, Medical Device Directives (MDD), and FDA Quality System Regulations (QSR).

Lithotech is EN ISO 13485:2012 and ISO 13485:2003 certified.

Regulations and Standards

Our management is truly committed to providing our customers with real value, complete compliance with all required regulations and standards, and a constant level of high quality, risk elimination and safety solutions – while continuously improving processes, safety and efficiency.
Lithotech has already sold over 300,000 units of its Nitinol Retrieval and Entrapping Devices worldwide.
Lithotech has received the “Dock to Stock” status four consecutive years, awarded by one of the leading medical device companies in the world – in recognition of our consistent level of excellent quality. Lithotech Medical – Putting our customers first.

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