Navigating the Proposed Regulatory Framework for SaMD
Tuesday, April 28, 2020 | Noon CST
This webinar will have a 45 minute presentation followed by 15 minutes of Q&A.
- Updated AI and ML methodology and policies for SaMD
- Enhanced algorithm development and revision
- Improving algorithm data impartiality and objectivity
- Ensuring appropriate regulatory alignment for SaMD
This webinar is $395 and can be accessed by 3 email logins for your team to access remotely.
Software Quality Engineer
Quality and Regulatory Professionals
Manatt, Phelps & Phillips LLP
As a partner with Manatt, Phelps& Phillips, 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 AI-based image and physiological data analysis tools, to wearable sensors and complex therapeutic delivery systems, Yarmela assists clients in assessing FDA requirements and developing premarket strategies where necessary.
For More Information, Contact:
Division Director, Life Science Programs
+1 (312) 224-1693