Global accreditation for Glasgow health-tech firm
MR CoilTech
The medical device sector is one of the world’s most highly regulated, with manufacturers needing to meet stringent requirements to sell goods into UK, EU, US and other markets. If SMEs are not enabled to meet regulatory challenges, there is a risk that innovators will be unable to commercialise their ideas, impacting vital investment in the health tech sector and patients not benefitting from potentially life changing new technologies and devices.
MR CoilTech
MR CoilTech designs, tests and manufactures 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 in greater detail than previously possible. With rapidly growing interest in MR CoilTech’s products from commercial partners and MRI research centres worldwide, ISO Accreditation provides a mark of quality and competence.
Support and collaboration
InnoScot Health signed a contract with MR CoilTech in 2022 to provide and implement an ISO13485:2016 Quality Management System. Since then to present day, Innoscot Health provides regulatory advice and support and project management for the continuing development of head coils for research playing a significant role in helping the company navigate the regulatory landscape. This resulted in MR CoilTech receiving globally-recognised ISO 13485:2016 accreditation in April 2023 after being recognised by the British Standards Institution (BSI) for operating a compliant Quality Management System and meeting strict guidelines.
Our impact
Through on-going work with InnoScot Health, MR CoilTech has been successful in surveillance audits by BSI and continues to maintain its accreditation.
The prestigious ISO accreditation creates the opportunity to advance these devices to the global market, and recognises MR CoilTech as a reliable supplier of RF coils and accessories for ultra-high field MRI research, as well as its contribution to bringing the next generation of MRI scanners to market. The company growth also brings wider benefits to Scotland including new high-value engineering opportunities.
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.
Dr Shajan Gunamony, Director of MR CoilTech and Head of MRI RF Engineering at the University of Glasgow
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