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GLOSSARY PAGES
IN DEPTH DESCRIPTIONS OF SOME OF THE MOST IMPORTANT TERMS RELATING TO MEDICAL DEVICE QUALITY AND REGULATORY
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Quality Control System
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Unique Device Identification (UDI)
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Document Control System
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21 CFR 803 Medical Device Reporting
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FDA 510(k) Database
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MedWatch Form
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Medical Device Regulations
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ISO Medical Device Standards
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MDSAP
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Electronic Medical Device Reporting
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MEDDEV Vigilance
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eQMS
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Quality Management Process
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Medical Device Clinical Trials
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Medical Device Life Cycle
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Labeling Medical Devices
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Medical Device Reporting
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Document Control Standards
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Document Control SOP
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Document Control Plan
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FDA cGMP
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Electronic Batch Records
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ISO 13485 Audit
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Corrective Action Plan
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Canadian Medical Devices Regulations (CMDR)
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Risk Matrix
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CORRECTIVE ACTION VS PREVENTIVE ACTION
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CORRECTIVE AND PREVENTIVE ACTION FORM
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CORRECTIVE AND PREVENTIVE ACTION REPORT
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NONCONFORMANCE MANAGEMENT
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CORRECTIVE ACTION PROCEDURE
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POSTMARKET SURVEILLANCE
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MEDICAL DEVICE DESIGN
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ISO 13485 REQUIREMENTS
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FDA Audit
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Document Control
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EU MDR
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MEDDEV 2.7/1
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FDA QSR
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510k vs PMA
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FDA 483
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Quality Assurance vs Quality Control
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ISO 13485 Standards
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ISO 13485 Certification
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Design Controls
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Medical Device Classes
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Medical Device Design Verification
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What is DHF (Design History File)?
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What is Device Master Record (DMR)?
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What is Device History Record (DHR)?
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ISO 9001
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Quality Management Tools
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CE Marking
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ISO 14971
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Corrective and Preventive Action (CAPA)
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ISO 13485
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510K Submission
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21 CFR 820
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21 CFR Part 11
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QMS (Quality Management System)
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Quality Assurance (QA) Systems
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