ISO13485 certification is a significant milestone in our development and implementation of the QMS at King’s. With funding from Wellcome, UKRI and Research England, the QMS is now established to support MedTech innovation and translation. Thank you to the team and all who have contributed to this success.
Dr Clare Heaysman, Senior Lecturer in MedTech Regulatory Affairs and Director of the Medical Engineering Quality and Regulatory Team
13 November 2025
Medical Engineering Quality Management System receives ISO 13485 certification
The London Institute for Healthcare Engineering’s (LIHE) Medical Engineering Quality Management System has been certified by the British Standards Institute (BSI) to International Standard ISO 13485:2016.
Earlier this year, the Medical Engineering Quality and Regulatory Team based in LIHE undertook the second phase of an ISO 13485:2016 audit of their Quality Management System (QMS). After four days of auditing processes and procedures, the auditor gave their recommendation for certification, which is now published on BSI.
The QMS is a formalised system that documents processes, procedures and responsibilities for developing medical devices, from early proof-of-concept research right through to first-in-patient studies. The system supports adherence to the necessary regulations and standards.
Being certified to the International Standard ISO 13485:2016 means that the QMS consistently demonstrates its ability to provide medical devices and related services that meet customer and regulatory requirements, ensuring quality and safety. Holding certification builds consumer confidence and eases compliance and market access.
LIHE’s Medical Engineering Quality and Regulatory Team trains projects to use the QMS to support them in their technical file creation and adherence to medical device regulations. The team offers different work packages for design and development depending on the project’s objectives.
Projects using the QMS have resulted in at least four different spinouts and several successful clinical studies. For example, Fraiya is a School spinout with an AI platform for anomaly detection in mid-pregnancy scans. Fraiya joined the QMS in 2021 to document their design, development and risk management activities, which supported them to spin out and contributed to their subsequent regulatory approvals.
The Magnetic Resonance Minimal Motion (MR MinMo) is a head stabilisation device that joined the QMS in 2023. The device recently received a Letter of No Objection from the Medicines and Healthcare products Regulatory Agency (MHRA), so the device can be tested in the clinic. This is the first project using the QMS to get approval for clinical investigation.
The certification is a remarkable achievement by Clare and her team. Not only will this accelerate the translation of innovative devices designed and developed across King’s, the QMS is also essential for the delivery of the manufacturing services offered by MAISI.
Professor Anne Vanhoestenberghe, Professor of Active Implantable Medical Devices (AIMD) Technology and Director of MAISI Facility
Our Medical Engineering Quality and Regulatory Team play a vital role in a wider ecosystem that drives MedTech innovation, translating devices from bench to bedside. Achieving ISO 13485 certification is a testament to the team’s expertise and their dedication to advancing innovation and, ultimately, improving patient outcomes.
Professor Sebastien Ourselin, FREng FMedSci, Assistant Principal (Innovation), Head of School and Director of the London Institute for Healthcare Engineering
In this story
Senior Lecturer in MedTech Regulatory Affairs
Assistant Principal (Innovation)
Professor of Active Implantable Medical Devices