Root Cause Insights
your global Human Factors and Usability partner
At Root Cause Insights, we understand the importance of collaboration and communication in delivering successful outcomes for our clients. We work closely with our clients to understand their specific needs and requirements, and we strive to deliver tailored solutions that meet their unique challenges.
Committed to providing a quality service
We are committed to staying up-to-date with the latest global regulatory guidance to ensure that our clients receive the highest quality service possible.
Early-Stage User Research
Applying HFE early can lower overall development costs and reduce the project timeline by helping to design the right thing and design the thing right!
IFU Design
While mitigating risk by design is the first step of device safety, instructional materials are another way to support the safe and effective use of your device.
Formative/Validation Human Factors Testing
RCI conducts formative testing with the aim of providing you meaningful and practical data around your product in development.
Human factors validation testing (sometimes referred to as summative usability testing) is required by regulatory agencies to prove that your device is safe and effective to use by its intended users in its intended use environment.
Human Factors Documentation
Successful human factors (HF) documentation should tell the story of your product’s development, presented clearly enough for reviewing authorities to quickly grasp the rationale behind design choices.
IRB/Ethics Review
RCI’s IRB is registered with the U.S. Department of Health and Human Services (HHS) to review and monitor plans for biomedical research involving human subjects.
Regulatory Consulting (FDA, IEC, MHRA & Others)
We are happy to consult on the following guidance documents:
• FDA Guidance – Applying Human Factors and Usability Engineering to Medical Devices
• ANSI/AAMI HE75
• Usability Engineering File for IEC 62366-1,-2
• ISO 14971
• ISO 13485
Leadership
Chris Kim, MD
Founder, CEO
Chris holds a Medical Degree from the Perelman School of Medicine at the University of Pennsylvania, and he has been working in the area of medical and regulatory affairs for over 16 years.
Chris specializes in the strategic implementation of human factors and usability testing for both medical devices and consumer products. His clinical background helps give him medical insight into the safety and efficacy of a product while understanding the risks that may prevent a smooth regulatory process. Under his guidance, over 400 medical devices have successfully met their safety and regulatory requirements.
Chris teaches at the University of Pennsylvania and Jefferson School of Medicine about the medical device development process and is considered an expert in the area of human factors application to design.
Our Team
Josh Divaker
Human Factors Manager
Max Gadebusch
Senior Human Factors Engineer
Gianna Maaddi
User Researcher
Contact Us
Contact our professional and friendly team with any questions you may have about what we offer, or if you would just like a chat to start your project with us.
Email: info@rootcauseinsights.com
US Phone: +1 267-494-9335
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