Partner, Hogan Lovells
As a partner with Hogan Lovells’ FDA Medical Device group, Yarmela Pavlovic focuses her practice on the U.S. Food and Drug Administration's premarket regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices. Yarmela brings extensive experience in product development and product submissions (510(k)s, IDEs, and PMAs), as well as a variety of other device-related regulatory issues.
Yarmela has particular experience in the area of FDA regulation of digital and mobile health technology, as well as medical software and applications. From standalone apps to complex systems, Yarmela assists clients in assessing FDA requirements and developing premarket strategies where necessary.
Yarmela also regularly counsels manufacturers of In Vitro Diagnostic (IVD) tests. Her knowledge of FDA’s premarket requirements assists companies in developing efficient regulatory strategies and successfully navigating the pathway to market.
Yarmela regularly counsels clients regarding strategic plans that not only comply with government regulations, but also achieve their business objectives. She has authored a number of articles and been an invited speaker on topics related to mobile health, Health IT, and medical device premarket pathways.