Post-Market Surveillance:
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Post-market surveillance is a critical tool for patient safety, regulatory compliance, and continuous improvement, extending beyond simple complaint handling. The EU MDR mandates a proactive PMS approach, requiring integration with risk management and communication with regulators for safeguarding patients and company viability.
Key takeaways
- Post-market surveillance (PMS) is a strategic tool extending beyond basic complaint management
- It is critical for improving patient safety, ensuring regulatory compliance, and driving continuous improvement
- Under the EU MDR, a structured and proactive approach to PMS is mandated, requiring strong integration with risk management practices and ongoing communication with regulatory authorities
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