Atrotech's facilities, design, development, production, installation, servicing and distribution are in compliance with EN ISO 13485 "Medical Devices - Quality Management Systems - Requirements for Requlatory Purposes". Atrotech’s quality system is certified by TÜV SÜD Product Service GmbH, Munich, Germany.

Atrostim PNS V2.0 is CE marked. CE-marking is based on the EC certificate assuring the conformance to the Active Implantable Medical Device directive 90/385/EEC.


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