Certifications
The Digitec quality system complies with the following standards:
ISO 9001:2015
For the design, manufacture and servicing of microprocessor systems, industrial automation, X-ray image processing and transfer, and X-ray image management software.
ISO 13485:2016
For the design, manufacture, marketing and servicing of X-ray image processing and transfer systems and X-ray image management software.
Product certifications
MDR CERTIFICATIONS
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.