Iso 13485 Quality Assurance Course For Medical Devices

Iso 13485 Quality Assurance Course For Medical Devices
Published 1/2025
MP4 | Video: h264, 1920×1080 | Audio: AAC, 44.1 KHz

Master ISO 13485 Standards: Ensure Quality Management, Documentation, and Compliance for Medical Devices

What you’ll learn

In-Depth ISO 13485 Knowledge

Practical Implementation Techniques

Documentation Expertise

Comprehensive Quality Audits

Requirements

Description

Overview

Section 1: Introduction

Lecture 1 Scope

Lecture 2 APPLICATION

Section 2: Terms and Definitions

Lecture 3 Terms and Definitions

Section 3: Quality Management System

Lecture 4 GENERAL REQUIREMENTS

Lecture 5 DOCUMENTATION REQUIREMENTS

Lecture 6 QUALITY MANUAL

Lecture 7 CONTROL OF DOCUMENTS

Lecture 8 CONTROL OF RECORDS

Section 4: Management Responsibility

Lecture 9 MANAGEMENT COMMITMENT REQUIREMENTS

Lecture 10 CUSTOMER FOCUS

Lecture 11 QUALITY POLICY

Lecture 12 PLANNING

Lecture 13 RESPONSIBILITY, AUTHORITY, AND COMMUNICATION

Lecture 14 MANAGEMENT REPRESENTATIVE

Lecture 15 INTERNAL COMMUNICATION

Lecture 16 MANAGEMENT REVIEW

Lecture 17 REVIEW INPUT

Lecture 18 REVIEW OUTPUT

Section 5: Resource Management

Lecture 19 PROVISION OF RESOURCES

Lecture 20 HUMAN RESOURCE

Lecture 21 COMPETENCE, AWARENESS, AND TRAINING

Lecture 22 INFRASTRUCTURE

Lecture 23 WORK ENVIRONMENT

Lecture 24 Human Resources Health

Section 6: Product Realization

Lecture 25 PLANNING OF PRODUCT REALIZATION

Lecture 26 VERIFICATION OF PRODUCT

Lecture 27 CUSTOMER-RELATED PROCESSES

Lecture 28 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT REQUIREMENTS

Lecture 29 CUSTOMER COMMUNICATION

Lecture 30 DESIGN AND DEVELOPMENT

Lecture 31 DESIGN AND DEVELOPMENT INPUTS

Lecture 32 DESIGN AND DEVELOPMENT OUTPUTS

Lecture 33 DESIGN AND DEVELOPMENT REVIEW

Lecture 34 VERIFICATION REQUIREMENTS

Lecture 35 DESIGN AND DEVELOPMENT VALIDATION

Lecture 36 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

Lecture 37 PURCHASING – PURCHASING PROCESS

Lecture 38 PURCHASING INFORMATION

Lecture 39 VERIFICATION OF PURCHASED PRODUCT

Lecture 40 PRODUCTION AND SERVICE PROVISION

Lecture 41 THE USE OF MONITORING AND MEASURING DEVICES

Lecture 42 CONTROL OF PRODUCTION AND SERVICE PROVISION-SPECIFIC REQUIREMENTS

Lecture 43 INSTALLATION ACTIVITIES

Lecture 44 SERVICE DATA, INFORMATION, AND REPORT

Section 7: MEASUREMENT, ANALYSIS, AND IMPROVEMENT

Lecture 46 MEASUREMENT, ANALYSIS, AND IMPROVEMENT-GENERAL

Lecture 47 MONITORING AND MEASUREMENT – FEEDBACK

Lecture 48 INTERNAL AUDIT