NeurOptics

It is frequently said that the eyes are the windows to the soul. At NeurOptics, we believe that the eyes are also windows into the human body and offer a glimpse into important physiological information for clinicians in a noninvasive manner. We make devices which collect and process information from the human eye to facilitate medical decision making and enable clinical research.

 

NeurOptics maintains the highest quality standards and is ISO 13485:2003 certified by TUV.  Our Pupillometers are CE marked per Annex VI of the EU Directive 93/42/EEC.

QUALITY MANAGEMENT SYSTEM

ISO 13485 Quality System Certification (PDF format).  ISO 13485:2003 Certificate

US FDA Good Manufacturing Practice (GMP)

We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website.

View our FDA Certificate to Foreign Government.

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

TUV SUD Product Service GmbH (ID #0123), RIDLERSTR 65, D-80339 Munchen, Germany

EC Certificate Number G2M 09 04 68835 002

www.tuev-sued.de/home_en

GLOBAL REGULATORY REPRESENTATIVES

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.

EUROPE - Authorized Representative

Emergo Europe, The Hague, Netherlands

Telephone: +31.70.345.8570

http://www.EmergoGroup.com/services/europe