Human Factors
Ergonomics Factory collaborates with startups, SMEs, and world-leading MedTech and Pharma companies around the globe to support their design and development projects. Our experience enables us to efficiently onboard your project and provide your team with immediate, effective support.
Regulatory compliance
We are experts in defining and implementing human factors and usability engineering programs in line with IEC 62366-1, EU Medical Device Regulation (MDR), and US FDA quality system regulations and human factors guidelines.
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Regulatory guidance and strategy
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Process and documentation gap analysis
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Authoring and implementing SOPs, work procedures, and document templates
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Audit preparation and support
Operational project support
We provide informed, reliable support through all stages of the product lifecycle, from development to post-market stages in accordance with the latest EU and US regulatory requirements, per IEC 62366-1, EU MDR, and US 21CFR820.
Support is always tailored to the exact requirements of your project, whether you’re designing and developing your very own medical device, using an off-the-shelf solution, or bringing a legacy device into regulatory compliance.
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User needs and user requirements analysis
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Human factors and usability engineering planning
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Use specification and known use problems analysis
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Product and user requirements analysis
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Use-related risk management
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User interface (UI) specification and evaluation planning
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User interface design development
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Formative and summative validation testing, expert reviews, and threshold analysis
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Usability engineering file creation (UE) and human factors (HF) summary reporting (US)
Use-related risk management
A compliant human factors and usability engineering program is dependent on an ISO 14971 compliant risk management process that spans your entire product lifecycle.
Our team has significant experience identifying use-related hazards and establishing effective risk control including forward and backward traceability between risk items and their respective measures.
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Known use problem analysis
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Task analysis
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Use failure modes and effects analysis (uFMEA)
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Risk management reviews and reporting
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Risk assessment updates
Human factors submissions
We assist legal manufacturers with preparing a wide variety of submissions in accordance with applicable standards, regulations, and guidelines.
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Preparation of pre-meeting packages
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Human factors validation protocol submissions
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Threshold analysis
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Filing support for NDA, EUA, 510(k), deNovo, BLA, IND and CE mark certification
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Assistance with regulatory questions