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:
- Development of Risk Management Plan
- Definition of Personas
- Workshops for the identification of risks and mitigations
- Assistance to test mitigations
- Development of Risk Analysis and Risk Assessment
- Development of Risk Management Report
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:
- Technological knowledge that ensures the understanding of the product and academic sparring with the development team
- Management that ensures the participation and involvement of all relevant functions
- Understanding regulatory requirements that ensure that the product can obtain CE marking and 510(k) approvals
This means that our client no longer sees the risk analysis as a necessary evil but as an interesting input to obtain high quality products!
In summary, Philips Healthcare has obtained the following lasting value by working with Technolution:
- Improved quality of the Risk Management Process:
- 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
- Updates to the QA system for it to comply with applicable standards
- Quicker marketing approval