Despite major changes coming to the EU regulatory system in under two years, many companies are still scrambling to develop strategies for handling the MDR and IVDR implementation in the region.
Last month at DeviceTalks West, Abbott regulatory affairs director Caroline Leab Byrd, R&Q regulatory affairs director Nancy Morrison and 30-year regulatory vet Artha Nafie ran through some basic steps that companies should take in preparation for the shift in the regulatory landscape.
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