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.

Human Factors Engineering

Human Factors Engineering

Human Factors Engineering, or as some call it ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. This is accomplished by using the scientific method to view human behaviors and adapt devices to be better used by its users. When it comes to medical devices, this occurs during the usability engineering process, during which engineers use human factors analysis, testing, and validation to adapt the device’s design to ensure optimization.

Specifically for Medical Devices, engineers will assist in design optimization through human factors analysis, testing and validation through a usability engineering process. Sterling uses human factor engineering through the design process to ensure that a medical device is safe and efficient for any users.

Ways Sterling can assist you in your Human Factors Engineering

  • Identifying and tracing requirements related to usability
  • Identifying hazards and hazardous situations related to usability
  • Analyzing residual risk associated with usability
  • Assisting in implementing the user interface using usability engineering methods
  • Assisting in usability validation
  • Assisting in the preparation of a usability engineering file
  • Meeting the ISO 62366 Standard and FDA Draft Guidance for Applying Human Factors
Contact Us
  • Name
  • This field is for validation purposes and should be left unchanged.

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

Letters GLP, representing Good Laboratory Practice

February 14, 2022

Preparing for GLP Guideline Regulations in Medical Device Development

Preparing for GLP Guideline Regulations in Medical Device Development As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must...
Read More >
View More Blogs

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

July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
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