Risk Management Analysis and Eval

Back to IVDR Phase 1

The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints

Risk Management Analysis and Eval

Establish Risk Matrix (5x5) Harm Severity and Occurrence rate

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Update Risk Management Procedure

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Create list of Harms

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Literature Review / Comparative Data

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Create Quality Trend Reports for nonserious events

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Risk Management Plan

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Determine Usability Requirements for UFMEA

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Determine Product Structure for DFMEA

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Determine Process Flow/Map for PFMEA

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Create Quality Monitoring Plan for Risk Controls

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Risk Management Workbook / Analysis

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Risk Benefit Analysis

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Equipment / Mfg Aids List

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Risk Management Report

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Manufacturing Risk Analysis

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Biological Risk Assessment per 10993

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