IVDR Phase 1
Quality Planning
Quality Planning (QP) Procedure
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IVDR Transition, QP
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Transitional Requirements, QP
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Risk Management Transition, QP
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QMS IVDR Transition, QP
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Design File Remediation, QP
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Vigilance and Risk Management
Article 88 (1): During audits, “The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints”
Post Market Surveillance Procedure
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Post Market Surveillance Plan (PMSP)
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Complaint & Vigilance Analysis / Evaluation
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Internal, External Data Sources, Previous PSUR or PMSR
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Trend Analysis Report
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Risk Management Analysis / Evaluation
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CAPA
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Benefit Risk Assessment
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Risk Management Report
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Periodic Safety Update Report (PSUR)
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Summary of Safety and Performance (SSP)
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Performance Deliverables
Post Market Surveillance Procedure
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Post Market Surveillance Plan (PMSP)
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Internal, External Data Sources, Previous PSUR
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Performance Evaluation Plan/Report
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Post Market Performance Follow-up (PMPF) Plan
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Risk Management Analysis / Evaluation
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Benefit Risk Assessment
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PMPF Report
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CAPA
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Periodic Safety Update Report (PSUR)
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Risk Management Report
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Summary of Safety and Performance (SSP)
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Process Outputs
Procedures
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Work Instructions
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Templates/Forms
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Supporting Documentation
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