News / 05.05.2011

Surgimap Spine Receives EC Certificate; FDA Authorized

Nemaris Inc, the parent company of Surgimap is proud to announce successful completion of the TUV audit and receipt of the EC Certificate as shown below for the Surgimap Spine software. This marks a major milestone in our corporate growth. As per TUV SUD:

The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex II.
Scope of Certificate: Design and Development, Production and Distribution of Medical Imaging and Planning Software The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality system which meets the requirements of the listed standard(s).
Applied Standard(s): EN ISO 13485: 2003/AC:2009 Medical Devices-Quality Management Systems-Requirements for regulatory purposes.

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