Continuing success in managing our services - ISO compliance
Reading time required: 2 minutes.
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 the 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!
ISO 13485 Success!
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.
Conclusion
We know our customers appreciate our level of service, and this is partially because we focus on quality everywhere inside THAY Medical. We will continue in 2025 to continuously improve our services, our commitment to usable medical products and use safety of the products our clients will collaborate with us on! We will never stop being compliant as a company and ensure our Quality Policy is adhered to.
_________________________________________________________________________________________________________________________________________________________________
Who wrote this insight?
Our Author today was Greg Thay, Founder, Principal Human Factors Consultant.
Greg is our founder and principal - leading THAY Medical with thirty years of experience in medical devices, pharmaceutical and diagnostic products and AI. Greg has a passion for quality in healthcare. His strong belief is that we are all end-users of medical products and that we should all have the highest standards of looking after each other, regardless what we do in life individually. This belief leads Greg to focus the THAY Medical team to deliver each collaboration time after time, exceeding expectations and assisting to develop cutting-edge, innovative and usable medical products. Often the most successful products are the most usable ones!
If you want to discuss this blog post, please reach out to Greg below - I am sure he would love to hear from you!
Or, if you would like to know more on our services, please reach out to us below also! We would love to hear from you!