GLOSSARY PAGES

IN DEPTH DESCRIPTIONS OF SOME OF THE MOST IMPORTANT TERMS RELATING TO MEDICAL DEVICE QUALITY AND REGULATORY

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IEC 62304

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Bill of Materials

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Root Cause Analysis

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Predicate Device

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FDA Warning Letters

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Standard Operating Procedure for Medical Devices

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EU IVDR

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Technical File vs Design Dosier

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Notified Body

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Human Factors and Usability

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Wearable Medical Devices

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Customer Complaint Handling Process

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QMS Manual

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FDA 510k Approval

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FDA Form 483

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Quality Assurance Testing

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Quality Assurance Auditing

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ISO 13485 vs 9001

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Quality Assurance Process

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GMP Compliance

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New Product Introduction Process (NPI)

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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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