SOLUTIONS
Human Factors Intelligence™ Total Compliance™ Individual Usability Solutions™
Our solutions and services.
Question: What solutions and services do we offer and perform for our customers?
Answer: We offer the following solutions for medical products. Our solutions group our services between compliance-led services, innovation-led services and individual ccccccccusability solutions that are standalone. These services are what we do everyday for customers around the world. We hope you are our next customer!
Total Compliance™ Solutions
EU Medical Device Regulation (MDR) Usability Compliance
We support organisations to develop their medical products to meet the EU MDR requirements that include requirements needing usability or human factors data to mitigate (such as ‘use safety’, ‘ease of use’ and ‘effectiveness’). This includes working to Annex C of IEC/ISO62366-1 and ISO 14971 for legacy medical products already CE Marked and the main body of IEC/ISO 62366-1 and ISO 14971 for new medical products, and also includes compliance to many other international and local standards (DIN, EN, BS etc).
The EU MDR (2017/745) and the EU IVDR (2017/746) have requirements that need evidence of ‘use safety’ (risk management using ISO 14971) and 'ease of use’ (usability engineering using IEC/ISO 62366-1). We support organisation to maintain compliance and also to generate new evidence to support the requirements, and also to keep CE or CA certification.
US FDA Human Factors Engineering Compliance
We support organisations around the world to gain human factors knowledge on their medical products focused on the USA and its population in a compliance-driven manner. We focus on 100%, complete, absolute compliance to the Code of Federal Regulations (CFR) requirements, including those stated in Part 820.30 (Design Controls) and to a number of Human Factors Engineering focused guidances - specific to particular market submissions and authorizations.
For a 510k submission, we prepare the Human Factors Engineering File (supplementing the Technical File) to the specific Guidance (UCM 259760) whilst for an ANDA, we follow the specific guidance for a New Drug Application and perform a comparative human factors study. These are just some examples, regardless, whichever route is required, we ensure compliance and have ten years of success at this!
Individual Usability™ Solutions
US FDA Human Factors Validation Testing
We support organisations around the world to gain human factors evidence to support their market authorizations and submissions and to respond to FDA concerns. This is achieved by performing firstly a Pre-Validation Human Factors Test with a small sample of intended users to ensure the medical product is validatable, and then by performing a compliance-driven Validation Human Factors Test. In combination, this is a powerful method of achieving success and evidence to support use safety and effectiveness and to gain 100%, total compliance to the FDA guidances and the Code of Federal Regulations.
We perform these tests on all types of medical product, be it hospital-focused, home-focused or a combination. Typically, a Human Factors Validation Test takes 3-6 months to complete and we have good experience at performing these tests to achieve success first time!
Summative Usability Studies
We support organisations around the world to gain human factors evidence to support their compliance to IEC/ISO 62366-1 by performing Summative Usability Studies! Typically, only one is required for any development or post-market (legacy design change) effort since it is a summation of the Usability Engineering put into the medical product. It is performed prior to Notified Body or Regulator submission and uses first production product to determine that the medical product is both safe and effective.
We perform Summative Usability Studies globally except in the USA (see above) and in China. A study takes around 3-5 months to complete.
If you need evidence that your medical product is safe and effective, why not use us to perform a Summative Usability Study?
Readability Testing
We support organisations around the world to design, develop and enhance their instructional materials alongside medical devices to ensure they are readable, understood by the intended users and contain the right information. All too often instructional materials such as Instructions for Use (IFUs), electronic Instructions for Use (eIFUs), User Manuals, Quick Start Guides, Consumer Annexes, Patient Information Leaflets, websites, applications and online software is developed with the intention of being readable, but is rarely tested to be so.
When the user wants information, it should be where they expect to find it, in a manner they can easily understand and follow since they are reading the instructional material for a reason. We perform Readability Testing to the EMA Guidance requirements and complete a three-part test in around 6-8 weeks, with the final design of instruction readable, with evidence to support this in a Report.
Human Factors Intelligence™ Solutions
Use Error Prediction™
Predicting the future use of your medical device is possible with our unique service. Knowing potential future issues enables them to be designed-out, quantified and mitigated to acceptable levels. We research the context of use with actual users in multiple locations, performing contextual enquiry, ethnography and interviews to understand the real impact of use errors in the use environment, to predict what precursors there are in real use that drive use (medical) errors and then what users have to do to work with and around them. Real life is rarely perfection!
All research is recorded in a Report that shows which use errors are likely to be most prevalent, removing guesswork from Usability or Human Factors Risk Assessment, quantifying the probabilities of occurrence and enabling designers, engineers and scientists to design better user interfaces, medical devices and systems that have the best chance of meeting users expectations and requirements. Knowing is intelligence!
Remediation Usability Testing™
Knowing what users will do after they have made a use error or had difficulty is vital to know how really safe your medical device is. Our unique test method enables remediation to be understood and the results used to guide the design and development of your medical device to suit the unintended use much more. Real life is rarely perfection!
We set up simulated-use situations where the use error, close call, difficulty or confusion has happened, and we trend and analyse what happens next. Do users remedy the situation or panic? Do they know what to do next? Would they consult the eIFU or ask a colleague? These unknowns are rarely seen in standard usability studies, and so understanding remediation is vital to predict how safe your medical device is likely to be. The results support risk management and the highest levels of medical device design. Knowing is intelligence!
Our most recent projects delivered successfully!
A Summative Usability Study on a Pre-filled Syringe (PFS) system
(Q2, 2025)
THAY Medical performed a Summative Usability Study on a pre-filled syringe system in London, UK for a long-standing European customer to aid in their development and subsequent CE Marking submission. The study was performed as planned, to budget and timescales and feedback from the customer stated:
“Good collaboration, that helped improving the informational materials effectively - 4/5!”
A Safety Guide Study on a In Vitro Diagnostic system
(Q1, 2025)
THAY Medical performed a Safety Guide Study on an In Vitro Diagnostic system in the, UK for a long-standing US/UK customer to aid in their development and risk management. The study was performed as planned, to budget and timescales and feedback from the customer stated:
“We are very happy with the work THAY Medical did on this project. The team are very professional and experienced which helped us overcome challenges that the project faced. We would be very happy to work with THAY Medical on future projects! - 4/5!”
If you want to have successful tests completed on-time, to budget and to your expectations, then contact us!
Contacting us is easy..
Please enter your basic information into the form below and click ‘Send an Enquiry’ once you have completed it. A response to your email address will arrive within one day from our Principal Human Factors Consultant where your enquiry will be discussed with you. We look forwards to hearing from you!
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Fill in the form with your contact information.
Fill in the form with your needs and requirements.
Press the ‘Send and Enquiry’ button.
By sending us an enquiry we commit to:
> Respond within one day to your enquiry.
> Discuss your enquiry one-to-one with our Principal Human Factors Consultant.
> Agree non-disclosure and confidentiality to keep your medical product safe.