Validating a new radiology solution’s readiness for CE marking
User Studies, March 2022

Business situation

In November 2021, a global 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 next 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 their team in completing risk assessment activities.

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

  • Deliver a report to support Class 1 medical device CE marking approval.

Outcomes

Bertrand,
CEO

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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.

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. In [month] 2022, the client’s radiology device was officially approved for CE marking.

BENEFITS

01

First-time right human factors validation

02

Strengthened in-house competencies

03

Regulatory compliance and efficient approval

04

Increased speed to market

Updates

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