Quality Management System

An important objective for all developments made within our company is a continuously stable and high quality of our products and services.

Our product developments and services target applications and software for medical and industrial image processing. An important aspect within our company is to deliver products and services of continuously stable and high quality. Therefore, we establish and maintain an integrated quality and process management system consistently within the entire company. Quality routines are created that ensure the continuous improvement of our processes and the resulting products and services.

In the targeted markets for highly innovative medical and industrial software, only products of high quality, robustness and good usability yield broad acceptance among the customers. In order to achieve these objectives, all developments run through various cycles with different quality management steps, such that the results are guaranteed to be safe and reliable. In addition, each product undergoes various testing and evaluation stages before final approval.

Our success in good quality management practices is reflected by the achieved positive certification results:

Chimaera has achieved the following certificates:

  • DIN EN ISO 9001:2008 (pdf)
  • DIN EN ISO 13485:2012 + AC : 2012 (pdf)
  • EC Certificate: Annex II - excluding Section 4 of Council Directive 93/42/EEC concerning medical devices (pdf)
  • Chimaera FusionSync: FDA Clearance - Traditional Premarket Notification 510(k) (Opens external link in new windowpdf)

Link to current certificates:

Opens external link in new windowDQS - Database