Maisi

MAISI is a specialised and fully staffed facility to manufacture active implants and surgical instruments. In 2019, King’s College London – BMEIS (School of Biomedical Engineering & Imaging Sciences) was awarded £5.2M by the Wellcome Trust to establish a new facility for the controlled Manufacture of Active Implants and Surgical Instruments (MAISI), to be located at St Thomas’ Hospital (Lambeth Wing, 4th Floor). The facility will address the lack of specialised and regulated manufacturing facilities for prototype development of complex Class II & medical devices for first-in-human studies in the UK. For the devices to be used in patients, in particular for active implantable medical devices (AIMD), it is crucial to implement an appropriate Quality Management System (QMS). The QMS is being developed in combination with the Centre of Medical Engineering (CME), funded by the Wellcome Trust and EPSRC. MAISI includes a team of Engineers and Quality Managers and is being implemented in partnership with UCL and Newcastle University. The facility will deliver the full impact of innovative research by enabling the supply of prototypes for clinical evaluation, accelerating the translational pathway for patient benefit. It will promote design for manufacture amongst UK start-ups and academic teams, and support device manufacture along with the required documentation and validation. Enquiries: maisi@kcl.ac.uk Twitter:@maisifacility