Projects
Project experience includes supporting projects by determining critical path to ensure successful CE Marking and/or in-country registrations of new diagnostics, including self-test, point-of-care from pre-development stages through full product life cycle management.Experience also of supporting projects in providing global regulatory strategy for various worldwide product registrations including Europe (IVDR), US FDA [BLA and 510(k)], Health Canada, TGA Australia, ANVISA Brazil, MFDS Korea, Malaysia and WHO Prequalification of in vitro diagnostics.