Transfer of a production system for medical devices
A client wants to outsource the production of blood gas measuring devices from an EU country to Switzerland, increasing capacity at the same time. In this context, the country-specific legal and licensing standards need to be taken into account.
EXCO is required to redefine the operator requirements for the System and take responsibility for the technical planning and documentation. This is followed by the purchase of new production equipment, the transfer of part of the existing system to a new location and the qualification of the system.
The client contracts EXCO with the:
- Technical coordination of the suppliers,
- Creation of the operator requirement specifications
- Creation of the functional specifications,
- Presentation and completion of the risk analysis and the FMEA,
- Systems qualification (IQ, OQ, FAT, SAT).
Following the inventory analysis, the operator requirements for the system are redefined in workshops with the operators and in consideration of the country-specific legal and approval standards. The technical planning and documentation is created. The risk assessment identifies approx. 100 major risks. The two stage FMEA analysis includes approx. 2,000 elements.
In future regulatory requirements will increase. As a partner in providing technical services, EXCO frees up clients’ time, so that companies can focus on their core tasks.
- Relieving the clients‘ workload through EXCO‘s expertise in country-specific legal and licensing standards.
- Relieving the clients‘ workload by taking on the coordination work with the participating suppliers.
- Reduction of costs through system transfer and qualification from one single source.
Medical technology manufacturer, Switzerland/Austria
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