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Glasgow Healthtech Firm Gains Notable ISO Accreditation

Thom Carter

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Glasgow Health Tech Firm MR CoilTech Wins Notable ISO Accreditation
MR CoilTech, the Glasgow-based healthtech engineering company, has been awarded with a globally-recognised ISO accreditation from the British Standards Institution for the design, development, and production of medical device technology, in partnership with the University of Glasgow and InnoScot Health.

The firm designs, tests, and manufactures specialised radiofrequency (RF) coils. RF coils are the devices behind generating and receiving the signals required to produce images of the human body for new generation, ultra-high field MRI scanners.

The bettered resolution for scanning will enable researchers to learn more about brain conditions such as stroke, vascular dementia, brain tumours, Parkinson’s and Alzheimer’s Disease in greater detail.

The accreditation of ISO 13485:2016, which formally recognises MR CoilTech’s capabilities in developing and delivering high-quality RF coils, is set to accelerate the company’s access to the global market, providing the firm with the opportunity for immediate growth.

“We are delighted to receive ISO accreditation, a major milestone for MR CoilTech,” said Dr Shajan Gunamony, Director of MR CoilTech and Head of MRI RF Engineering at the University of Glasgow.

“Achieving this internationally recognised quality standard will provide assurance to our customers in the quality, safety and efficiency of our RF coils.

“This accreditation will support MR CoilTech to continue to grow and deliver devices world-wide to enhance advanced imaging and allow researchers to study images at an exceptionally high resolution, advancing research and perhaps leading to new ways to diagnose or treat patients.”

MR CoilTech an industry partner in the Living Laboratory for Precision Medicine programme – a University of Glasgow-led programme focused on healthcare innovations that can be adopted into clinical practice.

As part of the Living Laboratory Coil Development project, MR CoilTech and Glaswegian product design company Wideblue are establishing new body part-specific coils with the 7T MRI scanner to extend the imaging capabilities and use of 7T MRI to more parts of the body than currently possible.

MR CoilTech says that the ISO accreditation will now support the development of a defined route to market for the devices developed in the Living Laboratory programme.


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Barry Warden, Wideblue’s Managing Director, also commented, saying: “We have been working with MR CoilTech over a number of years, helping them with the design and development of their head coil.

“We are pleased to hear that they have received ISO13485 accreditation as it recognises all of their hard work bringing the next generation of MRI scanners to market.”

Further, Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, said: “We are delighted that MR CoilTech has successfully completed its ISO 13485:2016 audit and certification of its Quality Management System, and we are proud to have played a part in that journey through working very closely with the company to provide and implement their Quality Management System providing regulatory advice and support.

“ISO 13485:2016 is an internationally recognised quality standard, supporting the delivery of medical devices that consistently meet customer requirements and that are safe for their intended use.

“Importantly, it serves to confirm MR CoilTech’s status as a reliable provider of RF coils and accessories to the ultra-high field MRI research world.”

Thom Carter

Staff Writer, DIGIT

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