HE Consulting, Inc.

HE Consulting provides Human Factors and user research capabilities to manufacturers of FDA and EU regulated medical devices. Expertise spans the product life cycle from concept to post market surveillance and all facets of the development program; whether providing user needs and design inputs to engineering teams or consulting on user and patient safety related regulatory guidelines and quality initiatives. We can also help your organization establish user-centered practices that naturally lead to a more complete FDA submission and/or CE Mark application. Above all, we can contribute, through user centered design practices, to an optimally safe and easy to use product.

Core competencies include
• Speaking on and teaching user-centered design practice, human error assessment and resolution, and human factors regulatory requirements
• Usability testing – formative and summative
• User and clinical needs generation to provide initial design direction
• Task analysis and user requirements definition and verification as outlined in IEC62366
• User and patient centered design inputs through analysis and empirical testing
• Use Error Analysis and FMEA as outlined in Quality System Regulation 21 CFR 820 and IEC60601
• User centered design process as outlined in IEC62366 and FDA human factors guidelines
• Adverse event assessment
• CAPA resolution
• Direct FDA submissions of Human Factors activities

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