Human Factors

Looking to complete one of the most important regulatory components required for medical device design?

The World Of Understanding

Human factors is not just about patient safety and compliance, it’s about understanding. At BlueBridge Technologies, we understand how patients interact with digital devices and the extent of influence the design of a physical device, user interface and user journey has on these mediated experiences. We form this understanding by asking the right questions to help you identify requirements and understand their limitations. We then guide and inform your development process with real user feedback to maximise its efficacy.

Why Human Factors Matter

Involving the end user as early and as often as possible has a significant impact on the success of any development program. We provide an end-to-end medical human factors service that includes user research; task analysis and identification of critical tasks; use related risk analysis usability test protocol design; participant recruitment (patient, carers, and healthcare professionals); formative studies; reporting, analysis and design recommendation; human factors regulatory support; and summative validation studies. We’ve also developed reliable methodologies and analytical approaches to meet the demand for human factors engineering throughout development. We analyse the analysable, research the researchable and are honest about what is left.

Why Companies Choose BlueBridge Technologies

Human Factors is now a required regulatory component for medical device design. As an ISO 13485 certified design/engineering house, BlueBridge Technologies gives you access to a team of highly-skilled experts in ergonomics, psychology, engineering, product design and communications, all under the same roof. ISO 62366 and AAMI TIR 59 form the basis of how we approach formative and summative studies. This allows us to provide an end-to-end medical human factors service which reduces delivery cost and time; delivers more intuitive design, usability and information architecture; ensures compliance to all relevant standards; and improves speed to validation and regulatory approval. But more than anything, our varied expertise helps us to be pragmatic and adapt our thinking however diverse your needs and challenging your project.

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Core expertise

Cloud (SaMD)

Mobile (SaMD)


Supporting Disciplines

Validation And Verification (V&V)

Regulatory Compliance

Human Factors

Post market Surveillance


Data Science

Sensors & Electronics


Project Governance

Get In Touch

If you have the problem, we have the solution. To get started on your Human Factors journey, all you have to do is start by saying hello.