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
- 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).