FDA Medical Device Compliance and Enforcement - Webinar Recording/Transcript
FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan for This Year
What do CMMI and MDSAP mean for the software pre-certification program and de novo regulation?
Bethany J. Hills, Chair, FDA Practice and Aaron Josephson, Senior Director — both of Mintz Levin — will provide a comprehensive understanding of compliance and enforcement trends and the contextual relationship of policy and regulation. You’ll learn about:
- What areas the FDA targeted in inspections in 2018 and has focused on for enforcement in 2019
- The nuances in compliance areas that create risk and should be closely monitored in your quality system
- The differences and revisions in inspectional programs affecting all medical device regulatory and quality professionals
- Enforcement tools the FDA will be using in 2019 to ensure compliance and evolving trends in how the FDA seeks enforcement
- The business implications of FDA enforcement trends and compliance policy through its new initiatives
Keep up to date with the latest thinking on FDA medical device compliance and enforcement.