Prestigious ISO accreditation awarded to Glasgow health-tech company MR CoilTech

Glasgow-based engineering company MR CoilTech has been awarded globally- recognised ISO accreditation from the British Standards Institution (BSI) for the design, development and production of medical devices, in partnership with the University of Glasgow and InnoScot Health.

MR CoilTech design, test and manufacture specialised radiofrequency (RF) coils, the devices responsible for generating and receiving the signal required to produce images of the body, for new generation, ultra-high field MRI (Magnetic Resonance Imaging) scanners.

The specialised, world-leading coils developed by MR CoilTech enable greater resolution brain scanning, supporting researchers to learn more about brain conditions such as stroke, vascular dementia, brain tumours, Parkinson’s and Alzheimer’s Disease in greater detail than previously possible.

MR CoilTech has a global reputation for delivering industry-leading advanced medical imaging technology, both across the UK and around the world.Now, this prestigious ISO accreditation (ISO 13485:2016), which formally recognises MR CoilTech’s world-leading capabilities in developing and delivering high-quality RF coils, will help to accelerate the company’s access to the global market, generating immediate company growth.

MR CoilTech is an industry partner in the University of Glasgow-led Living Laboratory for Precision Medicine programme – an internationally leading programme supported by UKRI Strength in Places Funding.

Building on previous successes developing advanced MRI imaging head coils between MR CoilTech and Glasgow-based Medical Device Design Company Wideblue Ltd, the Living Laboratory Coil Development project is establishing a pipeline of new body-part-specific coils with the 7T MRI scanner within the University of Glasgow’s Imaging Centre of Excellence to extend the imaging capabilities and use of 7T MRI to more parts of the body than currently possible.

There is already a rapidly growing interest in MR CoilTech’s products from commercial partners and MRI research centres worldwide and ISO accreditation will now support the development of a defined route to market for the devices developed in the Living Laboratory programme.

Creating opportunity to advance these devices to the global market will see further company growth for MR CoilTech, bringing benefits to the Glasgow area including new high-value engineering opportunities that will make Glasgow the go-to location for RF coil development.

Dr Shajan Gunamony, Director of MR CoilTech and Head of MRI RF Engineering at the University of Glasgow (pictured, credit: Martin Shields) said: “We are delighted to receive ISO accreditation, a major milestone for MR CoilTech.

"Achieving this internationally recognised qualitystandard 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.”

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.”

Barry Warden, Managing Director, Wideblue said: “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.”