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Support

BulbiTech AS offers support to those who would like to acquire our products. BulbiTech AS offers on-site and online training programs, which are performed by either our own staff or the certified staff of our authorised reseller(s). Our sales and support desk is availabe during office hours (9:00 - 17:00) to help you with any questions you may have, whether it will be about the functionality of our BulbiHUB software, the functionality of the BulbiCAM or any other question that you may have.

 Standards and Regulations related to management systems

Our products and services adhere to:

  • ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
  • FDA QSR 21 CFR Part 820 Medical Devices - Quality System Regulation
  • ISO/IEC 27001 Information technology — Security techniques — Information security management systems — Requirements
  • GDPR - REGULATION (EU) 2016/679
  •  Standards and Regulations related to medical products

  • Medical Device Directive 93/42/EEC, as amended with 2007/47/EEC
  • IEC 62304 - Medical device software — Software life cycle processes
  • ISO 14971/ EN ISO 14971 - Medical devices -- Application of risk management to medical devices
  • IEC 62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • ISO 15004-1 / EN ISO 15004-1 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
BulbiTech AS assumes all responsibilities for the disposal of all parts of the equipment according to DIRECTIVE 2012/19/EU on waste electrical and electronic equipment (WEEE).