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 60601-1-6

  • IEC 62366-1:2015

  • IEC 62366:2007 / A1 (2014)

  • ISO14971:2007 & 2012





Neurology / Neurovascular

Wound Care

Hematology & Chemistry





General Surgery.png

General Surgery

Emergency Medicine

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


Medical Products

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.


Combination Products

  • Injection Pens

  • Prefilled Syringes

  • Transfer Devices

  • Inhalation Devices

  • Autoinjectors

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Medical Devices

  • Anesthetic Applicators

  • Apps for Imaging Systems

  • Blood Analyzers

  • Breath Analyzers

  • Bronchoscope System

  • Cardiac Mapping Systems

  • Catheter / Generator Systems


  • Electrical Stimulation Systems

  • Flow Diverter Stents

  • Laparoscopic Instruments

  • Negative Pressure Wound Therapies

  • Optometry Diagnostic Devices

  • Photocoagulation Systems

  • Portable Ventilators


  • Surgical Robotic Systems

  • Respiratory Ablation Devices

  • Resusitation Devices

  • Ultrasound Imaging Systems

  • Surgical Devices

  • Wearable Sensors

  • And More


User Profiles & Groups

Healthcare Providers

Lay Users

  • Caretakers

  • Parkinsons Patients

  • Smokers

  • Physicians

  • Surgeons

  • Pharmacists

  • Physical Therapists

  • Nurses (RN, LVN, Scrub Nurse, Nurse Practicioner)

  • Technologists

  • Reprocessing Technicians

  • Pharmacy Technicians

  • Medical Assistants

  • And More

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.


Use Environments

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 :(


Home Environment

  • Indoors

  • Outdoors


Patient Transport

  • Ambulences

  • Automobiles


Healthcare Facilities

  • Operating Rooms

  • Post-op Recovery Suite

  • Exam Rooms

  • Outpatient Surgery Centers

  • Pharmacies