Digitec Srl operates in the radiology sector, designing and customising hardware and software systems capable of acquiring, processing and managing medical images.
The company was founded in 1985 from the idea of a group of enthusiasts with a dream: to develop digital technologies to assist humankind. Indeed, humans are the benchmark and central figure in all our research, products and services. We believe that technology becomes true innovation only when it is of service to humankind.
Innovation, experience and enthusiasm are therefore our corporate philosophy. Over the years, we have broadened our horizons by investing in human resources, research and development and specific training: a constant process that has led us to surprising results.
And it is this strong focus on research and the ongoing investment in new technologies that allow Digitec to remain at a high level on the international scene of medical devices.
Digitec is born, a specialist in image digitisation
HD Digital radiology
A high definition digital radiology system is created with a completely electronic acquisition process that will replace the traditional method with radiographic plate
Healthcare quality certification
The company obtains certification of its quality system with extension to specific requirements for medical devices
Digital medical image transfer and communication system
Development of systems on PC with dedicated software boards that enable communication of medical images with the most common transmission tools and the DICOM 3.0 protocol
Radical change with dynamic detectors
Design and production of digital systems with large format dynamic detectors with the possibility of fluoroscopy cycles quickly alternated with graphy cycles
Digitec joins dental and vetinary sectors
Based on the skills and experience it has acquired over the years, Digitec broadens its application to dental and vetinary sectors
Increase in turnover and personnel
Digitec significantly increases turnover and invests in personnel, with a team consisting of graduates in various areas (electronic, computer, physical and mathematics engineers)
Launch of Tiresya
Digitec celebrates 35 years of business with the launch of Tiresya, the new platform on which all software solutions are based
Digitec is equipped with a quality system that complies with the provisions of the following standards:
ISO 9001:2015 for the design, production and assistance of microprocessor systems, industrial automation, systems for processing and transferring radiographs, and software for managing radiographs
ISO 13485:2016 for the design, production, marketing and assistance of systems for processing and transferring radiographs, and software for managing radiographs
All this has allowed Digitec to CE-mark its products in the specific sector of radiography in accordance with the provisions of Directive 93/42/EEC of 14 June 1993 and subsequent amendments.
The same quality is ensured for the design, manufacture and sale of electronic boards for industrial automation, thanks to the system’s compliance with the ISO 9001:2015 standard.
Harmonized Technical Reference Standards:
EN 62304:2006+A1:2015 CSV Consolidated version: Medical Device Software – Software life cycle processes.
IEC 62366-1:2015: Medical devices – Part 1: Application of usability engineering to medical devices.
EN ISO 14971:2019/ A11:2021: Medical devices. Application of risk management to medical devices.
ISO/TR 24971:2020: Medical devices — Guidance on the application of ISO 14971
EN ISO 15223-1:2021: Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
ISO 20417:2021: Medical devices – Information supplied by the manufacturer.
IEC/TR80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software.
IEC 61910-1:2014: Medical electrical equipment – Radiation dose documentation – Part 1: Radiation dose structured reports for radiography and radioscopy