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EU MDR Vigilance & Trend Reporting: A Deep Dive into CAPA and FSCA Decisions
This episode explores the critical operational hotspots in medical device vigilance under regulations like the EU MDR. We examine the pressures for faster, higher-quality incident investigations, the complexities of making accurate MDR reportability decisions, and the nuances of establishing effective trend reporting thresholds. Discover how these vigilance activities are directly linked to your CAPA system, FSCA decisions, and the overall credibility of your Post-Market Surveillance (PMS) system during Notified Body audits. Key Questions: - How can you speed up incident investigations…
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