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structured dialogue
13 June 2025
Structured Dialogue: A New Way to Communicate Proactively with Your Notified Body
Structured Dialogue is a valuable, early-interaction tool under MDR that helps manufacturers clarify...
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PMCF Proactive Monitoring
20 March 2025
Post-Market Clinical Follow-Up (PMCF): Ensuring Continuous Proactive Review of Medical Device Safety and Performance
Ensure MDR compliance with PMCF! Learn key steps, best practices & download ready-to-use templates....
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WET balance with different requirements
18 March 2025
WET (MDR Article 61) vs WET (MDCG2020-6): Understanding the Differences and Benefits for Medical Device Manufacturers
WET under MDR Article 61 vs. MDCG 2020-6: Understand key differences, compliance benefits, and evidence...
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