Clear design isn't enough! Regulatory success demands structured, compliant usability documentation. Whether for CE-marking, FDA or NMPA approval, we help you align your Usability Engineering process with the standards that matter.
Why Regulatory Support is Essential for Human Factors Compliance
Human Factors and Usability are core components of medical device regulations across global markets. IEC 62366-1 and its practical guidance IEC 62366-2 require a structured process for identifying, evaluating and mitigating use-related risks throughout development. In parallel, the MDR/IVDR demand clear evidence that the product can be used safely and effectively by the intended users under real-use conditions. The FDA requires Human Factors Validation for most high-risk medical devices.
Without properly planned and documented usability work, approval delays, rejections or recalls become real risks.
Fulfills IEC 62366-1, ISO 14971, MDR/IVDR, FDA and NMPA requirements
Enables traceability of user needs, risks and design decisions
Strengthens your Design History File and Technical Documentation
Helps avoid late-stage regulatory issues or costly test repetitions
Aligns Human Factors with risk management and clinical evidence
What’s Required by IEC 62366-1, MDR/IVDR & FDA?
IEC 62366-1 Requirements
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Use Specification
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Context of Use Analysis
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Identification of Use Errors & Hazard-Related Use Scenarios
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Formative Evaluation(s) and Design Iterations
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Summative Evaluation (Validation)
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Usability Engineering File (traceable, audit-ready)
MDR / IVDR Requirements
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Demonstration of safe & effective use by intended users
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Integration of usability and risk control documentation
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Alignment with GSPRs (General Safety and Performance Requirements)
FDA Human Factors Guidance
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Human Factors Validation Study for critical tasks
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Use error analysis with root-cause assessment
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Representative users, environments and instructions
Our Regulatory Usability Services
Whether you're starting from scratch or optimizing your documentation before submission, we provide end-to-end support:
We identify existing gaps, develop a regulatory-aligned usability strategy, and align your development process with the relevant requirements.
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Review of existing usability documentation
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Gap analysis against IEC 62366-1, FDA and MDR/IVDR
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Development of regulatory-aligned usability strategies
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Definition of scope, milestones and required outputs
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We create or optimize audit-ready usability documentation, seamlessly integrated into your technical documentation and risk management system.
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Creation or review of the Usability Engineering File
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Integration with Design History File (DHF)
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Mapping to risk management and GSPRs
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FDA-ready submission documents (e.g. Human Factors Summary)
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We provide objective evidence that your product can be used safely and effectively by the intended users.
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Validation plan (IEC 62366-1 & FDA compliant)
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Definition of critical tasks and hazard-related use scenarios
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User recruitment and test execution
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Use error root-cause analysis and validation report
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We prepare your teams for audits, regulatory submissions, and questions from notified bodies or the FDA.
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Coaching for QARA and development teams
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Preparation for notified body or FDA questions
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Templates, SOPs and checklists aligned with international standards
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Review of usability sections in the Clinical Evaluation Report or Risk Management File
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Everything about Usability and UX for Medical Devices
Explore our full range of services across the entire usability engineering process. Whether you need targeted support in a specific phase or guidance throughout the full development cycle – our services adapt to your needs. Learn more about each offering and find the right support for your project.
Usability Engineering
Design medical devices that are safe, intuitive and compliant. We guide you through the usability engineering process – from concept to submission.
User Research
Understand real user needs and reduce risks early. We uncover insights that lead to better medical products.
UX/UI Design
Make complex technology easy to use. We design intuitive interfaces for medical devices and digital health solutions.
Your Benefits from Expert Regulatory Support
Compliant Usability Documentation
Aligned with IEC 62366-1/-2, MDR/IVDR, ISO 14971, FDA & NMPA
Faster Approvals
Smoother CE-marking, FDA 510(k), or De Novo submissions
Reduced Risk
Fewer regulatory hurdles and minimized risk of delay
Stronger Know-How
Stronger internal understanding of human factors and usability requirements
