REGUALTORY REQUIREMENTS
Build a solid understanding of US FDA and EU-MDR/IVDR requirements to ensure full compliance.
DATA ANALYSIS METHODS
Learn about data sources and analysis methods for signal detection and timely action.
OPERATIONAL MODEL
Operationalize your post-market surveillance system with an efficient and compliant process.
Become an expert in medical device post-market surveillance through a live, hands-on workshop.
Surprising fact: complaints handling is not post-market surveillance.
Since the EU-MDR (and IVDR) formalized explicit requirements for post-market surveillance for medical devices, manufacturers have struggled to implement an efficient process to ensure full compliance.
One reason is that post-market surveillance is seen as an extension of complaints handling.
However, post-market surveillance involves monitoring several data sources, not just complaints. It is expected to help facilitate timely action to emergent safety signals.
Plus, EU-MDR has extensive requirements for periodic reporting to provide evidence for continued safety and effectiveness.
This is why establishing a nimble, yet fully compliant, post-market surveillance proves to be challenging in practice.
This workshop will help you build a solid understanding of regulatory requirements, data sources and analysis methods, and an operational model you can implement in your QMS.
Register Today!
Start building your post-market surveillance expertise today!
