Events, Webinars and Deadlines
Our calendar informs on industry events, upcoming compliance deadlines, as well as new Obelis webinars.
Navigating U.S. FDA Medical Device Regulations: Pathways & Lifecycle Compliance
May 26 @ 4:00 pm – 5:00 pm
| Entering the U.S. medical device market requires a clear understanding of FDA regulatory requirements throughout the entire product lifecycle. This webinar will guide you through the key elements manufacturers must consider when placing a device on the U.S. market and maintaining compliance over time. Our experts will cover essential topics including: ✅Device classification ✅Regulatory pathways (510(k), De Novo, and PMA) ✅Labelling requirements ✅Post-market surveillance obligations ✅UDI implementation ✅Implications of the FDA’s new Quality Management System Regulation (QMSR) Join us to gain practical insights into navigating the FDA regulatory framework and ensuring your medical devices remain compliant from market entry through post-market monitoring. |