THAY Medical have been performing Human Factors Validation Tests for over ten years. In this time we have performed over thirty successful studies, all exceeding expectations. We know what is needed to make the process as easy as possible, to meet budgets and to meet deadlines as well as to be compliant 100% of the time. Our in-house expertise of Human Factors Engineers, working to our ISO 13485 Quality Management System (certified for Human Factors Engineering) together with a tight collaboration with the manufacturer or developer. Success is frequently based upon understanding, knowledge, experience, budget, management and close teamwork.

Our current best practice is to de-risk the Human Factors Validation Test by performing a smaller Pre-Validation Test beforehand if a final Formative Usability Study has not been performed. What this does is to ensure the product (system) design is as complete as possible from a use-risk perspective and to ensure everything is working as intended. This is based upon our experience in meeting the FDA requirements. The process is exactly the same, just fewer study participants are evaluated and is classed as a verification of the product (system) design or design change and is generally only performed when there are unknowns in the user performance or use-based risk levels.

Our Process:

Our process for performing Human Factors Validation Test is a 12-step sequence:

Our process is based upon a combination of all FDA relevant guidance’s to ensure compliance, but also best industry practices. Our process is driven by our customers and reflected in our Quality Management System to ensure we continuously improve our service and exceed the expectations of customers and the US FDA.

Our capabilities:

We have performed Human Factors Validation Tests for over 30 customers and offer the following flexibility in use environment and participants for any study. We can perform the Human Factors Validation Test in over 20 cities within the USA to suit the demographics of the intended use of the medical product:

THAY Medical have performed many Human Factors Validation Tests in the USA with a variety of medical products. We are confident we can perform a Human Factors Validation Test for you to exceed your expectations and meet time schedules and budgets!

Recent Human Factors Validation Tests:

Although we would love to shout about our recent Human Factors Validation Tests, we are bound by confidentiality by some of our customers so we are unable to show you who used us, and what new medical technology was evaluated, but we can detail the following:

• Human Factors Validation Test: [Medical Device] Cryoablation System, evaluated in Chicago, USA, 2024.

• Human Factors Validation Test: [In-Vitro Diagnostic] Blood Sampling System, evaluated in Chicago, USA, 2024.

• Human Factors Validation Test: [Medical Device] Wound-care System, evaluated in San Antonio, USA, 2024.