QUALITY POLICIES

Achieve higher standards

No product or device bears the name Werfen unless it meets our standards of excellence. We are proud to put quality above all else.

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Quality is our priority

Our Quality System has been certified in accordance with ISO 13485:2016 since 2016.

Leventon FDA Registered Establishment since 1985.

ISO Certificate

The International Organisation for Standardisation (ISO) published ISO standards and their purpose is to define the safety, reliability and quality requirements of products and services.

ISO 13485:2016

Demonstrates that Leventon provides products and services that constantly meet customer expectations, and consistently pursues the goal of improving customer satisfaction, using the risk management approach in all processes of the quality management system.

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ISO 13485:2016

MDSAP Certificate

Leventon is certified by the MDSAP (Medical Device Single Audit Program). This regulatory certification is recognized by the Authorities of five countries: United States (FDA), Australia (TGA), Canada (Health Canada), Brazil (ANVISA) and Japan (PMDA and MHLW)

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MDSAP Certificate