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What is Clinical Monitoring of Spinal Implants about?

This document provides recommendations for clinical monitoring of new and existing joint replacement and spinal implants. It covers definitions, reference documents, pre-market clinical investigations, post-market clinical follow-up, and data requirements. Recommendations include establishing an expert panel for new devices, risk-based monitoring, using registries for post-market data collection, and stratifying legacy device data by variant, component, and patient population to demonstrate safety and perfo

Author

ibrahim kademoglu

Language

EN