Specialised and regulated facilities for the manufacture of Class II & III medical devices for first-in-human studies in the UK.

MAISI is a national facility for the Manufacture of Active Implants and Surgical Instruments, located at St Thomas’ MedTech Hub. We aim to streamline the clinical translation of healthcare engineering research and address the lack of specialised and regulated manufacturing facilities within healthcare settings. Our dedicated manufacturing cleanrooms and regulatory support services are deployed for small batch production of complex devices for use in human studies. The Class IIb and Class III devices we can produce include Active Implantable Medical Devices (AIMD) and complex surgical instruments. Our cleanrooms will operate under a certified Quality Management Systems (QMS), and we offer dedicated Regulatory support for compliance to the requirements of the UK MHRA and new Medical Device Regulation.

This support is provided through a team of over 10 experts with years of industry experience in Quality and Regulation. The MAISI experts are a crucial element of the executive support King's provides to promising spin-outs and SMEs hosted at the flagship London Institute for Healthcare Engineering (LIHE)

MAISI is a new 120sqm facility operating two Grade ISO-7 Cleanrooms within a certified QMS, with Grade ISO-5 Laminar Flow and Grade ISO-8 prep room.  

MAISI realises the vision of Profs Ourselin, Donaldson and Vanhoestenberghe.  It was established in 2023 by King’s College London School of Biomedical Engineering & Imaging Sciences, in partnership with UCL and Newcastle University, with the support of a £5.2 million grant from the Wellcome Trust.