MDR Phase 1
Quality Planning
Quality Planning (QP) Procedure
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MDR Transition, QP
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Transitional Requirements, QP
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Risk Management Transition, QP
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QMS MDR Transition, QP
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Design File Remediation, QP
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Vigilance and Risk Management
Article 93(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
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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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Clinical Deliverables
Post Market Surveillance Procedure
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Post Market Surveillance Plan (PMSP)
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Internal, External Data Sources, Previous PSUR or PMSR
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Clinical Evaluation Plan/Report
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Post Market Clinical Follow-up (PMCF) Plan
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Risk Management Analysis / Evaluation
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Benefit Risk Assessment
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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 Clinical Performance (SSCP)
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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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