Usability Engineering Services for Medical Devices and 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 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.

Quality System Gap Analysis for Human Factors Requirements

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


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User Research

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

  • Task Analysis & Workflow

  • 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

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Usability Testing

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.

  • Participant Recruitment (Layusers and Healthcare Professionals)

  • 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

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. 


Complaint Management

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