QUALITY REGISTRATIONS
AEMPS
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.
CE
European CE Mark and Export Certificate Annex 1 and 2 number 1080/2020-CLV issued by the Spanish Agency for Medications and Healthcare Products (AEMPS) 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
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.
ISO 9001 and 13485
Institutions
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).
Memberships
Kanteron Systems member/participant/supporter of the AI in Health Partner Alliance, Horos Project, OpenCB, dcm4che, OHIF, VIT Salud, the Global Alliance for Genomics and Health, Genomic Medicine Alliance (GA4GH), BioVal, ITI, and IHE International.
Compliance
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.
AWARDS AND HONORS
Some thought we're the best (and we NEVER paid for it):
2016 Top 15% of analyzed software startups according to rating agency EarlyMetrics
2016 Selected by the European Commission as Top European Scaleup and Next European Unicorn
2016 California Impact Challenge in Precision Medicine Award
2016 Selected among “the most promising emerging digital health companies” by TechTour
2016 Digital Health Venture Forum award
2016 Selected as a member of the #ScaleUpClub by “Silicon Valley Comes to the UK”
2016 “One of the hottest 50 UK tech startups superstars” by CityAM
2016 Two post about Kanteron in Microsoft's Blog: one about Kanteron and the NHS, and the other about Kanteron's story
MEDIA COVERAGE
Corp. Reg. Kanteron Systems S.L.U. reg. 2005-2021 T8249 L5540 F4 S8 HV106897 I/A11 (28.01.22)
made with ♥ in Valencia (Spain)