Spanish Medical Device Manufacturer License number 7506-PS, applicable to the development and manufacture of Software for the storage and visualization of medical information and images, valid until December 2024.
European CE/1 Mark as required by Article 12 of the Medical Devices Directive 93/42/EEC and conformity assessment for
medical devices in section 2.5 of Guidance MEDDEVs.
FDA regulatory status (as medical digital data system, medical image storage device, and medical image communications device) according to the 21st Century Cures Act (Cures Act – Public Law No. 114-255) Sect. 3060/C/D/E excluded from definition of “device” software.
Institutions from Regional (such as The Chamber of Commerce or the Valencia Exports Institute IVEX), National (such as The Spanish International Trade Institute ICEX or the National Innovation Corporation ENISA), and EU levels (through the European Fund for Regional Development and the Gateway Program) have recognized Kanteron Systems’ relevance, by approving us in several R&D and collaboration programs (such as PIPE, the Corp. Innovation Promotion Plan, or APEX).
Kanteron Systems complies with the Universal Guidelines for AI, Electronic Industry Citizenship Coalition Code of Conduct (“EICC Code of Conduct”) and our products and services are covered by Product Liability Insurance provided by Chubb Insurance Company. Kanteron Systems has earned the Cyber Essentials badge from the UK Government for following computer security best practices.
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