Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

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

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

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
Contact Us
  • This field is for validation purposes and should be left unchanged.

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.

Share this!

Resources

United States of America and Medicine button on keyboard

March 17, 2022

What Country Leads the World in Medical Innovation

We’ll get right to the point. The answer to the question, “what country leads the world in medical innovation?” is the United States. Medical industry professionals all over the world...
Read More >
View More Blogs
5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos
active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis