The 2021 MIMAS Implant Safety Workshop will take place on September 15–16, 2021!
At this virtual event, the results of the EU-funded MIMAS project will be presented. Leading experts from the U.S. FDA, MRI vendors, medical implant manufacturers, test houses, and academia will complement the discussion on current methodologies and standards for MRI safety evaluations of passive and active implantable medical devices, the 2019 update to the ASTM F2182 test standard, and future safety assessment needs in the context of, e.g., parallel transmit MRI or smart implants. The speakers representing the project are from the Physikalisch-Technische Bundesanstalt (PTB), Istituto Nationale di Ricerca Metrologica (INRiM), National Physical Laboratory (NPL), Istituto Ortopedico Rizzoli (IOR), and ZMT Zurich MedTech AG (ZMT). The invited speakers include Sunder Rajan (U.S. FDA), Michael Steckner (Canon Medical Research USA) and Johan van den Brink (Philips Healthcare), Gregor Schaefers (MR:comp), Paul Stadnik (Biotronik) and Arcan Erturk (Medtronic).
MIMAS – which stands for Medical Implant Manufacturers' Safety procedures – is a joint research project under the European Metrology Research Program (EMPIR). The goal of the project is to enable medical implant manufacturers to demonstrate the compatibility of their products with MRI safety regulations by providing innovative, metrological sound and legally safe methods that will enable better and safer access to MRI for patients in Europe.
Being the provider of the first FDA-qualified computational modeling Medical Device Development Tool (MDDT), accelerating the approval process in the pre-market device submission of AIMDs, ZMT has been playing a key role in a number of MIMAS work packages. These include the development of anatomical human models sufficiently detailed for in silico medicine, the advancement and validation of numerical computational tools for the simulation of electromagnetic fields and temperature distribution inside anatomical models, or the development of validated methods for quantifying real-time implant-induced hazards during MRI exposure.
The agenda and more information on the registration can be found here.
The event is open to anyone interested; please register at the website above.
Looking forward to seeing you at this exciting event!
ZMT Zurich MedTech Team