InnoScot Health has congratulated its partner MR CoilTech on being awarded ISO 13485:2016 accreditation

Glasgow-based MR CoilTech received the official certification after being recognised by the British Standards Institution (BSI) for operating a compliant Quality Management System and meeting strict guidelines.

The organisation – set up in 2015 to commercialise a radio frequency (RF) coil device for the new generation of ultra-high field MRI scanners – succeeded in demonstrating its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

MR CoilTech’s coil device contains an array of antennae that pick up signals from the body, which can then be processed by the MRI scanner to generate the MR image. The RF coil enhances the image that can be produced by the scanners.

InnoScot Health signed a contract with MR CoilTech last year to provide regulatory advice and support – and is pleased that the accreditation has now been confirmed, underlining its commitment to delivering devices that meet strict quality standards.

Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, said: “We are delighted that MR CoilTech has successfully completed its ISO 13485:2016 inspection and certification of its Quality Management System, and we are proud to have played a part in that journey.

“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.”

She added: “The company is an undoubted success story, and we are certain that the certification will provide a springboard to even greater achievements.”

MR CoilTech’s coil device contains an array of antennae that pick up signals from the body, which can then be processed by the MRI scanner to generate the MR image. The RF coil enhances the image that can be produced by the scanners.

The company moved to Glasgow’s Queen Elizabeth University Hospital (QEUH) in 2016 with the goal of accelerating the development of the technology. A key attraction of coming to Glasgow was the facilities at the QEUH, notably the Clinical Innovation Zone and Imaging Centre of Excellence with its 7 Tesla MRI scanner. This scanner is one of only 75 worldwide and Glasgow is the only site in the UK where it is based in a clinical setting.

With the 7T MRI scanner CE Marked, there is a unique opportunity to develop MR CoilTech’s RF coil devices to the requirements of clinicians.