We help you develop medical devices that are safe, intuitive to use and compliant – through a Human Factors and Usability Engineering approach tailored to your needs.
Why Usability Engineering Matters
In medical technology, usability engineering is more than a regulatory checkbox – it’s a strategic advantage. With HUMAN FACTOR LAB, you turn usability into a driver for safety, compliance and market success.
Achieve market success beyond regulatory approval
Prevent risks before they impact patients
Ensure regulatory compliance with confidence
Streamline development with user-centered design
Create future-ready medical devices
Our Human-Centered Approach, Aligned With IEC 62366-1
We apply a structured Usability Engineering process – adapted to your product, your team and your development stage. Our approach ensures that your medical device is not only safe and effective, but also truly usable in real-world conditions.
Whether you're designing a new device or optimizing an existing one, we integrate usability activities seamlessly into your product development and regulatory strategy.
Understand the context of use
Identify use-related risks
Develop and refine user interface concepts
Conduct formative and summative evaluations
Our Services for a Compliant Usability Engineering Process
We help you establish a robust and compliant Usability Engineering process to systematically develop safe and user-friendly medical devices. From process integration to audits and documentation, we ensure your product meets regulatory requirements while prioritizing usability and patient safety.
Building internal competence for the implementation of regulatory usability activities.
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Introduction to IEC 62366-1 and Usability Engineering
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Joint development of the use context and regulatory requirements
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Clarification of roles and responsibilities for usability teams
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Integration of a complete Usability Engineering process into existing development workflows.
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Creation or optimization of your Usability Engineering Plan (UEP)
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Integration into existing processes (e.g., Design Controls, QMS)
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Support in process documentation and SOP development
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Prototyping your idea to gather user feedback and validate the proof of concept for your product.
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Developing a streamlined strategy to achieve proof of concept with minimal resources
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Testing the idea in real-world use scenarios to validate its functionality
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Creating a detailed development plan and evaluating the innovation potential
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Collecting early user feedback to inform product iteration and refinement
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Offering expert Usability Engineering with a deep understanding of user research, UX/UI design, human factors, and regulatory compliance, ensuring seamless integration of usability at every stage of product development.
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Full-cycle Usability Engineering, from concept through development and testing
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Seamless integration into any stage of the product lifecycle, ensuring compliance and validation
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User research, real-world testing, and ongoing support for product iterations
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Discover All Our Services Along the Usability Engineering Process
Our interdisciplinary services combine user research, UX design, usability testing, quality, risk and regulatory documentation – all aligned with MDR, IVDR and FDA Guidelines.
User Research
Understand your users deeply through usability studies and task analysis. We help you design products that minimize use errors and meet real-world needs.
UX/UI Design
With a focus on usability and human-centered design we ensure compliance with IEC 62366-1 and FDA guidance documents.
Validation
Ensure safety and compliance through formative and summative evaluations. We conduct critical usability validation in line with FDA, ISO 14971 and IEC 62366-1 requirements.
Quality & Regulatory
Navigate complex regulations like MDR/IVDR and FDA guidelines. We streamline the path to market with compliant usability engineering files.
Unlock the Benefits of Effective Usability Engineering
Faster Regulatory Approval
Structured usability activities and documentation aligned with standards like IEC 62366-1 and ISO 14971 streamline your path to certification.
Lower Development Risk
Early identification of use-related risks helps avoid critical errors and costly redesigns – saving time, money and resources.
Improved Product Quality
Usability engineering ensures your product is not only safe and effective, but also easy and satisfying to use. Fewer or even no trainings at all are needed.
Better User Experience
By focusing on real user needs and contexts, we design solutions that are intuitive, reduce cognitive load and fit seamlessly into clinical workflows.
Stronger Market Position
A usable product is a competitive product – better adoption, fewer complaints and higher customer satisfaction.
Frequently Asked Questions
We support medical device manufacturers of all sizes – from early-stage start-ups to global MedTech companies. Whether you’re developing software, hardware, or a combination product, we tailor our usability engineering support to your needs.
Yes. Both the MDR (EU) and the FDA (US) require usability engineering as part of the product development process. IEC 62366-1 outlines the expected steps. Skipping them can lead to delays or rejection during submission.
Ideally, usability activities start in early development – but it’s never too late. We adapt our support whether you’re starting from scratch or need to fix gaps before a submission.
We combine strong design and UX expertise with deep knowledge of regulatory standards like IEC 62366-1. You get hands-on support from a team that understands both usability and compliance.
Absolutely. We create or review all required documentation, including use specifications, task analysis, formative/summative test reports, and the full Usability Engineering File – ready for your auditors or Notified Body.
