Expertise You Can Trust
At UserWise, our human factors consultants have worked on a vast variety of medical devices and combination products across numberous medical disciplines, use environments, and user groups. From crafting relevant justifications to creating an accurate model of the use environment for the summative testing, our team can lead you through the entire process.
Regulations & Standards Compliance
UserWise human factors consultants work with our clients to assure compliance to the following regulations, standards, and guidances as they relate to the usability engineering process.
FDA CDRH Guidance: Applying Human Factors Usability to Medical Devices (2016)
21 CFR Part 820.30 (c), (d), and (f)
IEC 62366:2007 / A1 (2014)
ISO14971:2007 & 2012
Neurology / Neurovascular
Hematology & Chemistry
I love your images Garrett!! We need to create a few more for different disciplines. I’m showing Shannon what we have around 1pm Thurs Nov 1
From prefilled syringes to complex robotic surgery systems, UserWise human factors consultants have a breadth of experience implementing the usability engineering process for medical devices and combination products for small start up through fortune 500 companies, and in between.
Apps for Imaging Systems
Cardiac Mapping Systems
Catheter / Generator Systems
Electrical Stimulation Systems
Flow Diverter Stents
Negative Pressure Wound Therapies
Optometry Diagnostic Devices
Surgical Robotic Systems
Respiratory Ablation Devices
Ultrasound Imaging Systems
User Profiles & Groups
Nurses (RN, LVN, Scrub Nurse, Nurse Practicioner)
Garrett, can you update the image for a layuser? You can use this image but remove the mask and put hair on him. We’ll also want to be sure they scale the same.
From highly technical products that are used in healthcare facilities by health care providers to self-delivered products that are used at home, and in between, UserWise human factors consultants have experience considering how different use environments impact the overall risk profile and use of medical products.
I like these images. Let’s keep this simple. Can you make a picture of an ambulence? Do you know how to adjust the sizing on the spacers with more finite resolution? I want these centered below but it is not doing it :(
Post-op Recovery Suite
Outpatient Surgery Centers