Certifications

Design, production and technical assistance of systems and software for the management of radiographic and fluoroscopic images in medical radiology applications. Design, production and technical assistance of hardware for the radiology industry.

Design, production, placing on the market and service of systems of X-ray images elaboration and transferring and software for management of radiological images.

Product certifications and conformity

This has enabled Digitec to obtain CE marking for its radiology medical devices in accordance with Directive 93/42/EEC as amended and subsequent Regulation (EU) 2017/745.

Software libraries that are not medical devices are developed in accordance with the requirements of Regulation (EU) 2023/988.

The electronic devices manufactured by Digitec (racks and electronic boards) comply with the applicable Directives (Low voltage and/or Electromagnetic compatibility).