Validating a new radiology solution’s readiness for CE marking

Human Factors Validation Study

Business situation

A Swiss medical device company engaged Ergonomics Factory to perform a human factors validation study. Conducted in Switzerland, the study aimed to verify that the client’s new radiology solution conformed with European health, safety, and environmental protection standards, thus making it suitable for CE marking approval.

The Challenge

During the design and development phase of this innovative radiology solution, the client had already conducted several formative human factors studies of their own. However, they required greater human factors expertise to plan a design validation strategy that would comply with EU and US regulatory requirements.

The human factors validation study would need to be highly cost-effective. To prevent any misallocation of resources, notably time, stakeholders wanted absolute confidence that the final study would comply with regulatory requirements and expectations. We also agreed to grow their in-house expertise to prepare for future product development.​

The client’s ideal study partner would need to:

• Consolidate previous formative human factors studies’ findings.

• Support the planning and preparation of the client's design validation activities.

• Perform a highly cost-effective human factors validation study in Switzerland.

• Support their team in completing risk assessment activities.

• Deliver a report to support medical device CE marking approval.

The Solution

Ergonomics Factory reviewed the client’s user interface, human factors, and risk-related documentation and consolidated the findings of previous formative human factors studies. We revised the risk assessment documentation with the client’s in-house quality and risk management representatives. Leading up to the study, we developed a human factors validation study protocol and participant screener.

The client recruited the participants in accordance with the participant screener and organized the test site at a local hospital. Ergonomics Factory’s human factors engineers executed the study sessions while the client’s trained staff collected data using predefined note-taking sheets.

Our team then analyzed the study results and delivered a comprehensive study report. We supported the client’s risk assessment, including benefit-risk assessment, to successfully complete the human factors and design validation activities.

Outcomes

The client’s human factors validation study was completed, with thorough and compliant human factors engineering design history file documentation. We achieved full traceability between identified use-related risks and proof of the effectiveness of the implemented use-related risk control measures. Recently, the client’s radiology device was officially approved for CE marking.

"Thanks to Ergonomics Factory, our human factors validation study was a great success, and our in-house human factors engineering competency is much more robust now. I’m thrilled to continue benefiting from their experience."

Sophie,

Marketing Manager

BENEFITS

• First-time right human factors validation

• Strengthened in-house competencies

• Regulatory compliance

• Efficient health authority approval

• Increased speed to market

Updates

Now that the client has attained CE marking for their radiology solution, they to continue to work with Ergonomics Factory on strengthening the core competencies of their in-house design and development team.