Human Factors Validation Testing

1 Our expertise

THAY Medical have been performing Human Factors Validation Tests for over ten years. In this time we have performed over thirty successful validation tests, 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 ensures timely delivery and human factors data that is meaningful. Success is frequently based upon understanding, knowledge, experience, budget, management and close teamwork.

30+

Human Factors Validation Tests performed to date

2 Our process

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 medical 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 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. Compliance is the basis, with the aim to produce high-quality test data to prove use safety and effectiveness.

We can test anywhere in the USA, but prefer to go where science and data tell us to go - dependent upon the user population and where they live.

In these locations we simulate all clinical and home use environments and even perform testing in actual-use environments. We use a range of hospitals, universities, clinics, simulation centers and research facilities.

3 Our test locations

4 Participant Recruitment

For every validation test we recruit participants to take part, to test each device to evaluate its usability and human factors performance. We have a 100% success in recruiting the required sample size of participants into the validation tests we conduct. We have spent years honing our recruitment methods with our internal recruitment team. Coupled with a 100% success in gaining ethical approvals from IRB’s for patient involvement - it is a process that works. It is essential to the success we have had so far and is essential to our future success. Our Quality Management System aids us in this.

100%

Participant Recruitment

5 Our recent Human Factors Validation Tests

Whilst we would love to tell you about the excellent work we have completed, we cannot - at least not in any way that breaches any client trust and agreement. We can however detail the following:

  • Human Factors Validation Test: [Medical Device] Novel Woundcare System, evaluated in San Antonio, 2026.

  • Human Factors Validation Test: [Medical Device] State-of-the-art OCT Imaging System, evaluated in Chicago, 2025.

  • Human Factors Validation Test: [Medical Device] State-of-the-art Cryoablation System, evaluated in Chicago, 2025.

We currently have more validation tests in progress which increases our competance in this evaluation method in the USA.

6 Frequently Asked Questions on Human Factors Validation Tests

Q1: How long does a Human Factors Validation Test take to complete?

A Human Factors Validation Test takes between 4-6 months to complete depending on the complexity, size and amount of data.

Q2: Who is involved from THAY Medical in performing a high-quality Human Factors Validation Test?

THAY Medical assign at minimum of two or four Human Factors Engineers, the support of a Project Manager, a Quality Manager and our internal Recruitment Team to any Human Factors Validation Test to ensure the method, communicaton and data is optimal and the test performed smoothly and meeting all requirements including the sample size of participants required.

Q3: How much does a Human Factors Validation Test cost to outsource?

Typcially, for a one user group Human Factors Validation Test, it can start from £50k (€60k/$65k), most cost around twice this amount for a Human Factors Validation Test with 2-3 user groups.

Q4. What do I need to supply to THAY Medical to perform a Human Factors Validation Test?

The first thing we would need is finished product - production ready or first batch product or equivalent. Included in this are final design instructional materials (PILs, IFUs, Manuals, Websites, Apps, Quick Guides etc) and ideally with placebo medicines for drug delivery devices.

Q5. Can the data from a US-based Human Factors Validation Test be used elsewhere?

Yes, the data and Test Reports from a Human Factors Validation Test are frequently used to support CA/CE Marking, submissions to Notified Bodies and Regulators around the world. It is a validation of your product and as such is valid to show it is safe and effective to use.