Navigating Product Change Control: Balancing Innovation & Regulatory Compliance
Time: 2:30 pm
day: Day One Lunch & Networking
Details:
- Insights into the new FDA guidance, its objectives, and its implications for medical device submissions which include software
- Navigating the shift from traditional change processes to a forward-looking compliance strategy including regulatory strategies and optimizing documentation
- Practical strategies for managing change justification and maintaining compliance in a rapidly evolving regulatory landscape