Our Services
Discover safe and user-friendly solutions
Our human factors and usability expertise helps you create products and systems that are safe, intuitive, and enjoyable to use. We achieve this by thoroughly analyzing user needs and behaviors, applying ergonomic principles, and conducting rigorous usability testing. This ensures your products not only meet the highest safety standards but also provide a seamless and satisfying user experience, enhancing satisfaction and minimizing the risk of use errors.
Human Factors & Usability Engineering Regulatory Strategy
The process of Human Factors/Usability Engineering can be a little hazy and foreign. There are distinct hurdles associated with submitting to the EUMDR for your CE mark or the FDA for market clearance. Based on your particular device, HFS will develop a plan and guide you through each phase.
Formative & Summative Study Design
An essential component of Human Factors & Usability Engineering is research testing. Every aspect from organizing to creating protocols, task analysis, recruiting, obtaining IRB approval, and more. HFS is all inclusive and is able to provide expertise into all of these activities.
Quality Management System (QMS) Integration
Standard operating procedures will undoubtedly need to be created if your company wants to set best practices for its Usability Engineering or Human Factors operations. Having an SOP can help you present a strong collection of documentation in your submission package and demonstrate to regulatory bodies that you are in compliance.
Post Market Human Factors Assessment
The long journey of brining your product to market was achieved. Now you must monitor its performance with users. HFS has experience with various assessments to assure your post-market needs are addressed. Rather you need user interviews or surveys conducted, incident reports documented, or data analysis and iterative improvements.
IRB Preparation & Review
Nearly all research studies involving human participants require review and IRB approval. We can help your organization get through this hurdle by submitting your proposal and protocol to an authorized body for a quick turnaround.
Documentation Review & Recommendations
A successful device profile consists of multiple documents from the HF/UE process. HFS has a great deal of experience with each piece, so don't worry if these differ depending on the regulatory authority.
Formative & Summative Reports
Human Factors/Usability Plans
User Requirements Specifications (URSs)
User Needs Specifications (UNRs)
Risk Management (uFEMA's & URRA's)
Post-Market Surveillance Plans
Device Changes & Updates
Technical Assessments...the list goes on
Assistance with Regulatory Responses
After filing your validation report, did the FDA or EUMDR send you an information request, complete response letter (CRL), notification request, clarification request, or some other regulatory request? If so, we can assist you in navigating the intricate process of responding to these requests so you can launch your product or address any post-market concerns.
Product Labeling
HFS can assist in creating or improving your device labeling, regardless of whether it is an Information For Use (IFU), Quick Reference Guide (QRG), Information Reference Card (IRC), User Manual, Patient Manual, or something else.
Reduction of Errors in Manufacturing
Human Factors and usability play a crucial role in reducing errors in manufacturing. By understanding how people interact with systems, machines, and their environment, and designing those interactions to be intuitive and efficient, manufacturers can significantly improve safety, productivity, and quality. Key elements include understanding human limitations and capabilities, designing user-centered systems, optimizing the work environment, and continuous improvement.
