Philips Healthcare IntelliSave AX700
An anesthesia workstation
Philips Healthcare needed the right resources for the implementation of the risk analysis of a new complex device – an anesthesia workstation containing mechanics, electronics and software. Procedures and practices were to be updated according to current standards (ISO 14971).
Technolution has contributed with know-how to new processes and has thereby facilitated the preparation of the product risk management documentation for IntelliSave AX700. Through the cooperation with Technolution, Philips Healthcare has managed to speed up the CE marking, as Technolution contributed to FDA 510(k) approval.
Working closely with Philips Healthcare’s employees, Technolution has been responsible for the following:
We facilitated the Risk Management process in a high quality, in cooperation with all relevant Philips Healthcare’s departments, and not least created a foundation that in future will ensure the quality and speed of risk analysis in connection with 510(k) and CE marking. Technolution succeeded trough:
In summary, Philips Healthcare has obtained the following lasting value by working with Technolution:
- Optimized processes for Risk Management
- Optimized Documentation of Risk Management
- Involvement of relevant functions of the organization
- Identification of previously non-recognized risk, including using Personas and experience from other industries
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