MAISI - Manufacture of Active Implants and Surgical Instruments

Submitted by MAISI on Mon, 03/28/2022 - 13:51

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 and clinical trial 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 and Clinical Trial support for compliance to the requirements of the UK MHRA and new Medical Device Regulation. 

MAISI was established by King’s College London School of Biomedical Engineering & Imaging Sciences, in partnership with UCL and Newcastle University, with the support of a Wellcome grant of £5.2 million.

"With the support of Wellcome we are delighted to continue to build infrastructure that addresses the challenges to clinical translation of complex medical devices. This will ultimately contribute to our goal to accelerate the development and uptake of innovative technologies that improve health outcomes."

Professor Sebastien Ourselin

Disciplines

Physical Sciences & Engineering
Keywords
MAISI
Medical Device
Medical Devices
Manufacture of Medical Devices
Healthcare

 

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Contact Us

📧 Public Contact email
maisi@kcl.ac.uk
Telephone Number
02078489673
🏢 Address

St Thomas' Hospital
Westminster Bridge Rd
Greater London
SE1 7EH
United Kingdom

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