Perspective & Commentary
IVDR Transition: 5 Challenges and Solutions From the Field
In the transition toward the new IVD Regulation, May 2022 served as an important milestone for manufacturers applying for conformity assessments in the EU. Manuela Kaul, senior VP, global clinical affairs and regulatory affairs at bioMérieux, a world leader in in vitro diagnostics, is facing the new landscape firsthand. Here she discusses the challenges her teams have faced during this transition and what strategies have helped them find solutions.
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