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Wherever you are in your product development lifecycle,
Sterling can help.

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FDA Human Factors Documentation Support

Human factors engineering, or medical ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. The U.S. Food and Drug Administration (FDA) considers human factors engineering in device regulation because the safety of medical devices relies on them being used as intended, as well as their reliability. The FDA expects device developers to account for human factors within their processes.

The intent of the human factors process at the FDA is to ensure the development team demonstrates and documents:

  • Understanding of the users, use environments, and user interfaces
  • Understanding of user groups and their capabilities and limitations
  • Understanding of intended environments where the device will be used as well as unsuitable environments
  • Understanding of intended use and foreseen unintended uses of the device
  • Efforts to identify use-related error
  • Evidence for effective mitigations to user-related error
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Sterling can help.

Sterling has the experience and expertise to support the human factors documentation
Human Factors Documentation List
  • Use Specification
  • User Interface Characteristics Related to Safety
  • Known or Foreseeable Hazards and Hazardous Situation
  • Hazard-Related Use Scenarios
  • Use Risk Analysis
  • Use Scenarios for Summative Evaluation
  • User Interface Specification
  • User Interface Evaluation Plan
  • Indications for Use statement and Contraindications (if applicable)
  • Detailed device description, including the components and materials in the device and how it works
  • Picture or image of the device
  • Instructions for use
  • Labels for the product, which includes marketing materials, packaging, etc.
  • Comparison to another currently marketed device (if available)
  • Risk Management Files
  • Master Validation Plan
 required for your regulatory submission. Our services include:
  • Human factors documentation gap analysis
  • Human factors documentation remediation
  • Human factors testing support
  • Human factors ad hoc consulting

About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

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