Radiography of a success

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Digitec Srl operates in the radiology sector, designing and customising hardware and software systems capable of acquiring, processing and transferring 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.

35

years of experience

15

new employees in the last 4 years

38

years average age

8

million Euro turnover

25

of turnover for research and development

35

specialised professionals

70

of employees with degrees

11

sold systems

1985

Company founding

Digitec is born, a specialist in image digitisation

1990

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

1999

Healthcare quality certification

The company obtains certification of its quality system with extension to specific requirements for medical devices

2000

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

2008

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

2009

Entry into the dental and veterinary sectors

The company undertakes a path to develop in the dental and veterinary sector based on the skills and experience it has acquired over the years

2015

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)

2020

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:

IEC 62304:2006+AMD1:2015 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.

UNI CEI EN ISO 14971:2012: Medical devices. Application of risk management to medical devices.

UNI CEI EN ISO 15223-1:2017: Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

UNI CEI EN 1041:2014: Information supplied by the manufacturer of medical devices.

IEC/TR80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software.