About Us

We operate globally from our offices in the United Kingdom and Sweden

About THAY Medical

THAY Medical are a specialist Human Factors Engineering organisation who assist medical device manufacturers and pharmaceutical companies to develop medical products. 

Where a Clinical Research Organisation (CRO) will focus on the clinical aspect of a medical device, THAY Medical focuses on the Human Factors (HF) aspect of a medical device. The human factors of a medical product can be described as the interaction between the user and the device. We believe it is beneficial to apply the best human factors and usability engineering practices into device developments and post-market surveillance. Good user interaction reduces the occurrence of clinical errors in real life. 

We pride ourselves on complying with global regulations that are industry standard for medical devices – such as IEC 62366-1 and ISO 14971. In addition, we also work to the US-based FDA requirements and European CE regulations. All services are performed to our own ISO 13485 certified quality management system. 

Our core services include usability engineering, human factors testing, medical device design, and much more which can be found on our “services” page. We operate to the highest industry standards globally, with focus on always exceeding regulations and customer expectations. We offer a solution tailored to your needs that always will be compliant, effective, and of great value.

Our Offices

THAY Medical are located in two offices, in the UK and in Sweden.

In the UK, THAY Medical can be found in the beautiful countryside of Dorset. Here we continue to be inspired by the 360 degree views surrounding the office. It is from our offices that we continue to inspire and lead medical and pharmaceutical organisations to create usable products.

Our facility is equipped with a meeting room suitable for both physical and virtual meetings as well as our brand new home use test room which allows us to perform studies on site with access at any given time.

Qualifications

To make sure our company is performing at top level, we ensure our services are completed to the requirements of a rigorous, yet efficient quality management system. We are ISO 13485 certified and continue to gain additional accredited ISO’s.

What is ISO certification?

An ISO certification certifies that a management system, manufacturing process, service, or documentation procedure has all the requirements for standardization and quality assurance. 

ISO (International Organisation for Standardizaton) is an independent, non-governmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems.

ISO certifications exist in many areas of industry, from energy management and social responsibility to medical devices. ISO standards are in place to ensure consistency. Each certification has separate standards and criteria and is classified numerically. 

For instance, the ISO certification we currently hold at THAY Medical is ISO 13485:2016.

ISO 13485:2016

ISO 13485:2016 ensures that medical devices used in healthcare settings are designed, produced, installed and serviced to the highest standards.