Referencer
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Philips Healthcare Intellisave AX700

Philips Healthcare needed the right ressources for the implementation of the risk analysis of a new complex device

Case

Philips Healthcare was short of the proper resources for the implementation of a risk analysis of a new anesthesia device containing mechanics, electronics and software. Procedures and practices were to be updated according to current standards (ISO 14971).

Philips Healthcare needed support for:

  • The implementation of risk analysis and preparation of risk management documentation for the new device
  • Updating the risk management processes
  • Input to correspondence with FDA

In addition, Personas were to be defined according to the new requirement of IEC 60601 – ie typical users and their typical function in relation to medical devices.

Technolution

Technolution has contributed with know-how to new processes and has thereby facilitated the preparation of the product risk management documentation for Intellisave AX700. 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

Solution

Through the cooperation with Technolution, Philips Healthcare has managed to speed up the CE marking, as Technolution contributed to FDA 510(k) approval.

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

Technolution competences

Technolution has a unique combination See our competences
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of resources, which enables us to contribute to all phases of the project.

Technolution has worked closely with Philips Healthcare’s employees in development, quality, marketing and service. We have contributed with our knowledge to new processes. 

We used:
Research & development
Usabiliy & design
Medical devices
Quality assurance
Manufacturing
Project management

Our role

Technolution 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 by:

  • 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

The above has meant that the client no longer sees the risk analysis as a necessary evil but as an interesting input to obtain high quality products!

For further information:

Allan Spork

Managing Director


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