Before the pandemic, medical device, pharmaceutical and diagnostics firms were already laboring to meet regulatory deadlines. COVID-19 introduced new challenges that needed immediate attention. Demand for essential medical devices such as personal protective equipment and ventilators rose, while delayed elective procedures led to a lull for some medical device segments.
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Nancy has more than 30 years of quality and regulatory experience in the medical industry with U.S. and global regulatory submission experience. She has spent the last nine years with RQM+, working with startup, mid-size and multinational medical device and combination product companies. Nancy has been providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at small and large organizations.