EFRE Project ZiMT gets a visit from the FDA
As part of the EFRE project ZiMT, the Chair of Medical Technology was visited by the FDA (Food and Drug Administration) on May 17, 2018. In the US, the FDA is responsible, among other things, for the approval of medical devices and pharmaceuticals. The aim was to exchange views on the future of open and manufacturer-independent networking in operating theatres and clinics (according to IEEE 11073 communication standard) and to further synchronize the current approaches and procedures internationally. In a full-day workshop, results regarding approval strategies, modular risk management, standardization as well as test procedures and requirements regarding the human-machine interfaces for the novel approach were discussed. The current ZiMT approaches and procedures were evaluated very positively by the FDA and a follow-up date for a further exchange in the US is already planned.