Medfield has entered into an agreement with Intertek for tests according to standard IEC 60601-1 with applicable substandard guidelines for pre-hospital use as well as CE certification under the Medical Devices Directive, MDD Annex II. The tests will be carried out by Intertek Test House during Q3 2018 and in connection with these tests, ISO 13485-2016 certification audit is also carried out and certification of the technical file for CE certification of the Strokefinder MD100. Medfield and Intertek will now work out detailed plans for the implementation of these activities.
CE marking of MD100 is an important milestone in the establishment of the microwave technology in prehospital emergency care. The CE mark will open up for commercial sales on the European market to both ambulance organisations and emergency hospitals and will make the technology more accessible for further studies and product development.
“It is very satisfying that, in the MD100 development project, we have reached this milestone and that we now go into the detailed planning of certification and launch,” says Stefan Blomsterberg.
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