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).
MGS Design & Development has contributed know-how to new processes and facilitated the preparation of product risk management documentation for IntelliSave AX700. Through cooperation with MGS Design & Development, Philips Healthcare was able to accelerate CE marking, as MGS Design & Development also supported FDA 510(k) approval.
Working closely with Philips Healthcare’s employees, MGS Design & Development has been responsible for:
- 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 close cooperation with all relevant Philips Healthcare departments, and created a foundation that will ensure the quality and speed of future risk analyses in connection with 510(k) and CE marking. MGS Design & Development succeeded through:
- Technological knowledge that ensures understanding of the product and provides academic sparring with the development team
- Management that ensures the participation and involvement of all relevant functions
- Understanding regulatory requirements that ensure the product can obtain CE marking and 510(k) approvals
In summary, Philips Healthcare has obtained the following lasting value by working with MGS Design & Development:
- 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 unrecognized risks, including through Personas and experience from other industries
- Updates to the QA system for compliance with applicable standards
- Quicker marketing approval
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