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 health technology and use of artificial intelligence and machine learning techniques in healthcare, as well as FDA regulation of medical software and applications. From standalone apps to complex digital therapeutic systems, Yarmela assists clients in assessing FDA requirements and developing premarket strategies where necessary.
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.
- Panel: What's In Store for Medtech in 2019? | Tue. February 5 - 12:00 PM - 12:55 PM