Medical Device Glossary

Glossary

In depth descriptions of some of the most important terms relating to medical device quality and regulatory.

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IEC 60601

IEC 62304

Bill of Materials

Root Cause Analysis

Predicate Device

FDA Warning Letters

Standard Operating Procedure for Medical Devices

EU IVDR

Technical File vs Design Dosier

Notified Body

Human Factors and Usability

Wearable Medical Devices

Customer Complaint Handling Process

QMS Manual

FDA 510k Clearance

FDA Form 483

Quality Assurance Testing

Quality Assurance Auditing

ISO 13485 vs 9001

Quality Assurance Process

GMP Compliance

New Product Introduction Process (NPI)

Quality Control System

Unique Device Identification (UDI)

Document Control System

21 CFR 803 Medical Device Reporting

FDA 510(k) Database

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

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