THAY Medical gains ISO 13485 and ISO 9001 certification
THAY Medical has recently achieved the first of many steps to becoming a world-class innovator of medical devices in achieving ISO 13485 and ISO 9001 certification. Since incorporating late in 2014, THAY Medical has grown based upon a core competence of human factors engineering focusing on medical devices and drug delivery products.
Greg Thay, Managing Director, said: “To achieve internationally accepted levels of quality systems management so quickly, has for us been a priority. We need to work at the highest level and to achieve this, our staff need to perform human factors engineering in a compliant manner. Our clients and customers will benefit from this capability.”
The certification to both of these ISO standards shows that THAY Medical have adopted an industry-wide level Quality Management System, and will ensure continuous improvement in the methods used in delivering world-class human factors engineering and product development.
In addition to ISO compliance, THAY Medical ensure all work is performed to the latest regulatory standards and guidance. Human factors engineering is performed to IEC 62366-1:2015, the latest European directed regulation applied to medical devices, which is accepted in most countries world-wide. In addition, compliance to the US-based FDA human factors guidance document UCM259760, from June 2011, is worked to when a US pre-market authorisation is the eventual target. THAY Medical frequently perform human factors studies around Europe and in the USA to meet the requirements of these regulations.
THAY Medical is a human factors engineering consultancy as well as product development organisation. Our key focus is to use the science of human factors to determine the market gaps and trends, and use this knowledge to develop the next generation of usable medical devices and drug delivery products. In addition, we use the process of human factors engineering to produce evidence of use safety (verified and validated by human factors testing and risk management) and user interface optimisation. Usable medical devices are essential in the reduction of medical errors and the optimisation of their clinical use and performance.