Abstract

MAISI is a national facility for the Manufacture of Active Implants and Surgical Instruments. 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. We are open to work with any team developing innovative devices in the UK, whether you are an academic research group or an SME . We can work with you at different stages of your project, from early discussions about the practical implementation of an idea, and developing solutions to design challenges, to the manufacture of the final products. In this talk Anne Vanhoestenberghe (Director) will elaborate on our operational model and the actual manufacturing processes we will implement. Our focus is on Class IIb and Class III devices, including Active Implantable Medical Devices 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 with the requirements of the UK MHRA and new Medical Device Regulation.

The seminar should be of interest to anyone developing AIMD or complex surgical devices and who intends to test their innovation in a first-in-human study, in the near or more distant future.