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Risk management is an integral part of the medical device product. And the most important step is to document the risk management plan.
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medical device risk management report template
ISO 14971 is a risk managementstandard for medical devices.
3.1 RISK MANAGEMENT PROCESS |
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3.2 MANAGEMENT RESPONSIBILITIES |
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3.3 QUALIFICATIONS OF PERSONNEL |
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3.4 RISK MANAGEMENT PLAN |
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3.5 RISK MANAGEMENT FILE |
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4.1 RISK ANALYSIS PROCESS |
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4.2 INTENDED USE AND SAFETY |
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4.3 IDENTIFICATION OF HAZARDS |
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4.4 RISK ESTIMATION PROCESS |
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RISK EVALUATION PROCESS |
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RISK EVALUATION RECORDS |
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6.1 RISK REDUCTION PROCESS |
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6.2 RISK CONTROL OPTION ANALYSIS |
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6.3 RISK CONTROL IMPLEMENTATION |
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6.4 RESIDUAL RISK EVALUATION |
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6.5 RISK-BENEFIT ANALYSIS |
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6.6 RISKS CREATED BY CONTROLS |
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6.7 COMPLETENESS OF RISK CONTROL |
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OVERALL RESIDUAL RISK EVALUATION |
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OVERALL RESIDUAL RISK RECORDS |
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RISK MANAGEMENT REVIEW |
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RISK MANAGEMENT REPORT |
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MEDICAL DEVICE MONITORING |
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MONITORING YOUR MONITORING |
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Also see the NEW ISO 13485 2016 Standard for Medical Devices. |
This page summarizes the ISO 14971 2007 standard. It highlights the main points. It does not present detail. To get the complete plain English standard, please consider purchasing our Title 48: ISO 14971 2007 Translated into Plain English. Title 48 is detailed, accurate, and complete. It uses language that is clear, precise, and easy to understand. We guarantee it! Title 48 is 60 pages long and comes in pdf and doc file formats. |
MORE ISO 14971 PAGES |
RELATED LIBRARIES |
Updated on November 28, 2015. First published on February 28, 2011. | |||
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