GLOSSARY PAGES

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

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MedWatch Form

Medical Device Regulations

ISO Medical Device Standards

MDSAP

Electronic Medical Device Reporting

MEDDEV Vigilance

eQMS

Quality Management Process

Medical Device Clinical Trials

Medical Device Life Cycle

Labeling Medical Devices

Medical Device Reporting

Document Control Standards

Document Control SOP

Document Control Plan

FDA cGMP

Electronic Batch Records

ISO 13485 Audit

Corrective Action Plan

Canadian Medical Devices Regulations (CMDR)

Risk Matrix

CORRECTIVE ACTION VS PREVENTIVE ACTION

CORRECTIVE AND PREVENTIVE ACTION FORM

CORRECTIVE AND PREVENTIVE ACTION REPORT

NONCONFORMANCE MANAGEMENT

CORRECTIVE ACTION PROCEDURE

POSTMARKET SURVEILLANCE

MEDICAL DEVICE DESIGN

ISO 13485 REQUIREMENTS

FDA Audit

Document Control

EU MDR

MEDDEV 2.7/1

FDA QSR

510k vs PMA

FDA 483

Quality Assurance vs Quality Control

ISO 13485 Standards

ISO 13485 Certification

Design Controls

Medical Device Classes

Medical Device Design Verification

What is DHF (Design History File)?

What is Device Master Record (DMR)?

What is Device History Record (DHR)?

ISO 9001

Quality Management Tools

CE Marking

ISO 14971

Corrective and Preventive Action (CAPA)

ISO 13485

510K Submission

21 CFR 820

21 CFR Part 11

QMS (Quality Management System)

Quality Assurance (QA) Systems