IEC 62366-1, FDA Human Factors Engineering, IEC 60601-1-6
Human Factors & Usability Engineering Services
Usability Engineering & EUA Services for Medical Devices & Combination Products
UserWise offers human factors and usability engineering consulting services to companies developing medical devices and combination products. The UserWise team has proven experience helping small start-up companies through Fortune 500 organizations, successfully bringing their product development programs into compliance with international standards such as IEC 62366-1 and IEC 60601-1-6, as well as meeting current FDA expectations for human factors engineering. Our offerings span the entire product development cycle and can be tailored to meet specific organizational needs.
Additionally, UserWise can assist with usability engineering and regulatory support for your Emergency Use Authorization (EUA) applications to the FDA.
Quality System Compliance
The UserWise team has proven experience assisting medical device companies with compliance for meeting international and domestic human factors and usability engineering requirements. We provide gap analyses and compliance support for IEC 62366-1, IEC 60601-1-6, the MDR, as well as applicable FDA regulations and human factors guidance documents.
- Usability Engineering Gap Analyses
- Authorship & Integration of Usability Engineering Procedures & SOPs
- Audit Support for Notifying Bodies & Test Labs
- IEC 62366-1 & FDA Program Compliance
Use-Related Risk Analysis
The UserWise team can create templates for use-related risk analysis documentation or work within your standard risk management templates to ensure that appropriate use errors and risks are identified and mitigated.
- Use-Related Risk Analyses (Use FMEA)
- Design Requirement Development to Ensure Safe Use
- Control Mitigation Implementation to Reduce Use-Related Risk
From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, UserWise consultants can help you optimize your medical product design through the usability engineering process.
- Formative Usability Study Preparation, Coordination, Execution & Reporting
- Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals)
- Expert Review of Medical Product User Interfaces
- Cognitive Walk Throughs
Instructions and Labeling
Do you need help developing a user manual for your medical product? We can help! The UserWise team has assisted numerous medical device and combination product companies optimize their training programs, point-of-use reference materials and Instructions for Use (IFU). Let us do the same for you.
- User Manual Development & Optimization
Expert Review of User Instructions
- Quick Start Guide & Quick Reference Guide Creation
- Usability Studies to Evaluate Labeling
- Training Program Development & Optimization
- Training Video Development
In this unprecedented time, UserWise is ready to assist companies with COVID-19-related products, such as in-vitro diagnostic tests (IVDs), ventilators, and other medical products, to swiftly obtain and manage Emergency Use Authorization (EUA) by providing appropriate Human Factors Information to the FDA:
- Plan and Execute Usability Testing
- Support Scientific Evidence on Safety and Effectiveness
- Perform Expert Human Factors Review of Product Design and Labeling
- Develop Instructions for Use
- Produce Fact Sheets for HCPs and Patients
- Craft Risk-Benefit Analysis
- Optimize Post-Market Surveillance Activities to Uncover Use Issues
- Create or Review Point-of-Use Reference Material
- Develop Remote Product Trainings and Training Programs
Human Factors Validation Testing
Whether you need support in developing your FDA human factors validation strategy or require a partner for full summative usability validation study planning, execution and reporting, UserWise has helped our clients successfully navigate their product through usability testing to regulatory approval and we can do the same for you.
- Study Strategy
- Human Factors Validation Studies (Actual Use & Simulated Use)
- Participant Recruitment for Human Factors Validation Studies (Lay Users & Healthcare Professionals)
- Summative Evaluations
- Clinical Usability Studies
Human Factors Engineering Submissions
UserWise consultants have experience preparing medical device and combination product human factors submissions for FDA and regulators outside the U.S. Whether you need help with human factors strategy or preparing the full Human Factors Engineering (HFE) Report for FDA, the UserWise team stands ready to assist you through the entire process.
- Regulatory Strategy & Guidance
- Human Factors Engineering (HFE) Submission Reports for 510(k), de Novo, PMA, IDE, BLA, & NDA Applications
- Assistance with Human Factors Regulatory Submission Questions
Usability Engineering File (outside US) for IEC 62366-1
- Threshold Analyses
From defining appropriate use environments and users, to conducting searches for known use errors and hazards for on-market devices, to outlining specific tasks and workflows for using a product, UserWise can provide assistance in all areas of user research for medical devices and combination products.
- Known Use Error Summary & Literature Review
- Task Analysis
- Use Scenario Identification
- User Profiles & Personas for the Use Specification
- Use Environment Description for the Use Specification
The UserWise team can support your efforts to develop or strengthen your company's complaint management system infrastructure all while considering usability engineering best practices.
- Preparation of Scripts for Call Centers
- Preparation of Training Videos with Simulated Calls
- Methods for Documenting Use Errors
- Analysis of Complaint Reports
Human Factors Training
UserWise provides a variety of training courses on human factors and usability engineering to meet medical device and combination product companies exact training needs.
- 30-minute Briefing on the Benefit of Usability Engineering to Investors & Managers
1-hour Introduction to the Usability Engineering Process
1-day Course on Usability Engineering Process
4-hour Seminar on Usability Risk Reduction
4-hour Seminar on Usability Testing & Usability Validation
Training on IEC 62366-1, IEC 60601-1-6 & FDA Human Factors Engineering Guidances
- Complaint Management (handling calls, documentation, & analysis of reports)