ICU tech is your partner for medical production

  • ISO 9001 and 13485 certified
  • Production of prototypes
  • Production of small to mid-size series
  • Supply chain management
  • Production of systems
  • Final inspection including documentation and archiving
  • Ensuring traceability
  • Full Quality assurance
  • Support for certification

Technical consulting:

  • Optimization of the project in terms of reducing production costs and electromagnetic compatibility.
  • Execution of EMC tests (certified laboratories, both engineering and certification tests, ICU support).
  • Execution of tests for compliance with EN-60601 (certified laboratories, ICU support).


  • Purchase of production parts and subassemblies (ICU or external contractor, ISO9001).
  • Supply chain traceability.
  • Electronic circuit production in accordance with IPC Class III (external contractor ISO9001, ICU supervision).
  • Implementation of cabling (external contractor ISO9001, supervision of ICU).
  • Advice and execution of the housing (milling of finished housings, making molds for injection molding and production of housing, external contractor ISO9001, supervision of ICU).
  • Execution / adaptation of mechanical parts based on the provided documentation (external contractor ISO9001, ICU supervision).
  • Final assembly, testing, marking, packaging, shipping (ICU or external contractor, ISO9001).


  • Risk analysis (applicable to the production process).
  • Preparation of the assembly instructions (Master Production Control Record).