At RBC, we ensure intuitive and safe use of the products we design for you.
Our processes integrate human factors for medical devices during all phases of product development – planning, analysis, design, development, testing, and evaluation.
Medical Device Design & Development Services
Medical device design human factor studies at RBC primarily focus on the device’s user interface including the controls, displays, logic of operation, form and shape, weight and weight distribution, labels, and instructions. We ask questions such as:
- How will users receive information from the device?
- How will users interpret the information and make decisions about what to do?
- How will users manipulate the device, its components, and/or its controls?
- How will users prepare to use the device and perform maintenance?
The goal of human factors for medical devices is to design medical products that users can operate safely in real-world situations, leading to increases in worker productivity and improved performance at the point-of-care.
Other medical device human factors and usability considerations:
- How to make the device more intuitive to use?
- How to better communicate device status and operation?
- How to reduce reliance on user manuals or make manuals easier to understand?
- How to add safety features at each intersection (inter-device connections, power cords, leads, tubes)?
- How to make repair and maintenance easier?
Do you have the available resources and capabilities to transform your product development vision into a commercial medical device?
RBC Medical Innovations is ISO 13485 | ISO 9001 certified and FDA registered, with 25 years of experience supporting contract medical device design, development, and manufacturing. We focus exclusively on producing Class I, II, and III medical devices for FDA PMA or 510(k) clearance as well as international CE marking. Our clients partner with us because we have the available tools, resources, certifications, and expertise to transform their vision into reality.
510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.