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SUMMARY:Manufacture of Active Implants and Surgical Instruments - Anne Van
 hoestenberghe (Director) MAISI
DTSTART:20221013T150000Z
DTEND:20221013T160000Z
UID:TALK183704@talks.cam.ac.uk
CONTACT:Kirsty Shepherd
DESCRIPTION:MAISI is a national facility for the Manufacture of Active Imp
 lants and Surgical Instruments. We aim to streamline the clinical translat
 ion of healthcare engineering research and address the lack of specialised
  and regulated manufacturing facilities within healthcare settings. Our de
 dicated manufacturing cleanrooms and regulatory and clinical trial support
  services are deployed for small batch production of complex devices for u
 se in human studies. We are open to work with any team developing innovati
 ve devices in the UK\, whether you are an academic research group or an SM
 E. We can work with you at different stages of your project\, from early d
 iscussions about the practical implementation of an idea\, and developing 
 solutions to design challenges\, to the manufacture of the final products.
  \nIn this talk Anne Vanhoestenberghe (Director) will elaborate on our ope
 rational model and the actual manufacturing processes we will implement. O
 ur focus is on Class IIb and Class III devices\, including Active Implanta
 ble 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 re
 quirements of the UK MHRA and new Medical Device Regulation. \n\nThe semin
 ar should be of interest to anyone developing AIMD or complex surgical dev
 ices and who intends to test their innovation in a first-in-human study\, 
 in the near or more distant future.\n
LOCATION:Cambridge Graphene Centre Seminar Room
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