Continuing success in managing our services - ISO compliance

31 January 2025

THAY Medical are delighted to have again been audited by our Notified Body recently and are proud to achieve not a single non-compliance in our annual ISO 13485 audit! This was possible due to the hard work and dedication of the THAY Medical team and without their experience and quality management mentality, we would not continue to improve and better our internal procedures. These procedures create tjhe outputs that form our services - which is what our customers see and receive from us. So, we are proud to continue this at the highest standards!

Special thanks goes to Mark Batterbury, Quality Manager and to Natalia Yakovleva, People and Training Manager. Everyday throughout the year they continue to maintain and enhance the internal procedures and the health of our staff to ensure our services are at the highest levels. There are many facets of total quality management, but one we excel in is document control and another in staff training. These are just two to mention, but where we focused to ensure that our services do meet the expectations of our customers.

This year the company will continue its focus on total quality management and compliance. Standards and regulations are there to set a minimum and so by exceeding the minimum a company can perform well with its products and services. We expect new regulations and the continuation of existing ones. The Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) will continue to need usability and human factors inputs (for legacy medical products this is performed to IEC/ISO 62366-1 Annex C) and until 2028 we see this continuing. Last year the China NMPA released Human Factors Engineering guidance for medical products in China, the US FDA released guidance on Use-related RIsk Assessments for drug-device combination products and many more. So, the regulations continue to change and thus our quality management system evolves to keep up to date with these.

We know our customers appreciate our level of service, and this is partially because we focus on quality everywhere inside THAY Medical. If you wish to find out how excellent our services are, please contact us! We would love to hear from you!