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 bring 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.
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 and 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 and Usability Validation
Training on IEC 62366-1, IEC 60601-1-6 and FDA Human Factors Engineering Guidance
Complaint Management (handling calls, documentation, analysis of reports)
We have experience developing customized coursework to meet individual organization’s needs. Contact us to learn more.
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, as well as applicable FDA Regulations and Human Factors Guidance Documents.
Usability Engineering Gap Analysis and Informal Quality Audit
Authorship of Usability Engineering Operating Procedures and Integration with Existing Quality Systems
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.
Literature Reviews to Investigate Known Use Errors
Summary of Known Use Errors
Use Scenario Identification
User Profiles and Personas for the Use Specification
Use Environment Description for the Use Specification
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 appropriate risks are identified and mitigated.
Use-Related Risk Analysis and Use FMEA
Development of design requirements to ensure safe use
Recommendations for Control Measures and Mitigations to reduce Use-Related Risk
From Formative Evaluations on early prototypes to full Summative Usability Validation study planning, execution and reporting, UserWise has helped our clients successfully navigate their product through Usability Testing and we can do the same for you.
Early-Stage Usability Study Protocols and Reports (Formative Evaluations)
Usability Validation Study Protocols and Reports (Summative Evaluations)
User Manual Evaluations
Usability Study coordination and execution
Human Factors Engineering Submission Output
Whether you are submitting your medical device or combination product in the US or outside the US, Userwise can help your team summarize the entire Usability Engineering Process for regulatory agencies and notified bodies.
Human Factors Engineering (HFE) Submission Report (for 510(k), de Novo, or PMA application) with Consideration to Applicable FDA Guidances
Preparation of the Usability Engineering File (oUS) in Compliance with IEC 62366-1, Summarizing the Usability Engineering Process for Your Medical Device or Combination Product
Assistance Addressing Questions from Regulatory Agencies and Notified Bodies on Human Factors and Usability Engineering Submissions
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