SurgicEye receives the certification for their medical device quality management system according to the EN ISO 13485. The first audit of SurgicEye by DQS was a complete success and the company and processes were highly acknowledged by the auditors. The scope of the certification of the quality management system includes research, design and development, manufacturing, distribution and service of medical devices including software and hardware as well as consulting for medical device.

The certificate was an important milestone for SurgicEye towards the CE marking of Confident Surgery Suite 300, a 3D intra-operative SPECT imaging and navigation device. The planned product launch is scheduled for Feb 15, 2010. Furthermore, the certificate is important for OEM development, especially of software and devices for image processing and surgical navigation.

“The contribution of every single team member of SurgicEye for quality issues and their commitment for save and robust device and software development is outstanding” highlights  Moritz Hoyer, quality manager of SurgicEye. Furthermore he mentions “the infrastructure and servicing system perfectly implements all processes in an extremely effective way”. Made in Germany with high quality standards is the key for all activities of SurgicEye.