MCRA’s Human Factors and Usability Engineering team help you find the least burdensome testing pathway to regulatory clearance, while ensuring the safety and effectiveness of your medical device.
Human Factors and Usability Engineering in MedTech
Human factors engineering or usability engineering in the medical device field applies knowledge about human behaviors, abilities, and characteristics of medical device users to the interface design of medical devices. Human factors engineers examine how people interact with devices to reduce use errors, enhance safety, and improve user experience as well as patient care. Human factors validation testing evaluates whether a medical device can be used safely and effectively by its intended users.
Why Do I Need a MedTech Human Factors Expert
Human factors and usability engineering is critical to the success of a medical device as it directly impacts patient safety, clinical effectiveness, and regulatory compliance. The FDA recognizes usability engineering as an essential component of medical device design and requires manufacturers to demonstrate that devices can be used safely and effectively by intended users in intended use environment. A human factors expert can help you navigate the least burdensome testing strategies to ensure devices’ safety and effectiveness use and recommend device design improvements to mitigate use-related risks and improve user experience.
Your Experts in Human Factors and Usability Engineering
The MCRA Human Factors and Usability Engineering team includes clinical, regulatory and biomedical and mechanical engineers with extensive proven experience in the medical device innovation and design industry. MCRA’s team provides end-to-end usability engineering services, from ideation to market.
Human Factors/Usability Engineering Offerings
MCRA’s Human Factors and Usability Engineering team offers the following across our integrated service portfolio:
Assess usability testing strategy and regulatory requirements on usability testing based on regulatory strategy
Deficiency response service
Develop usability engineering documents:
Usability Engineering Plan
Use Specification
Task Analysis
Use-related Risk Analysis
Known Use Problem Report
Threshold Analysis
Comparative Use-related Risk Analysis
Formative Usability Study Protocol and Report
Summative Usability Study Protocol and Report
Formative and summative study design, execution, and reporting
Labeling Review
Post-market Surveillance Data Analysis
HFE/UE Report per Appendix A of the FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (2016)
