• Post category:StudyBullet-17
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The Complete ISO 13485 QA Course for Medical Devices
Master ISO 13485: Elevate Medical Device Quality Assurance

What you will learn

ISO 13485 Understanding: Gain deep knowledge of ISO 13485 for the medical industry, covering normative references, definitions, and quality management.

Quality Assurance Implementation: Acquire practical skills for implementing quality assurance in medical device manufacturing, ensuring ISO 13485 compliance.

Documentation for Compliance: Learn to create essential ISO 13485 documentation, ensuring compliance through policies, objectives, manuals, procedures, and more

Comprehensive Quality Audits: Master comprehensive quality audits, including matrix tracking and full audits, preparing for ISO 13485 standards alignment.

Description

Welcome to “The Complete ISO 13485 Quality Assurance Course for Medical Devices” – your definitive guide to mastering the intricacies of quality assurance in the dynamic field of medical devices!

In this comprehensive course, you will embark on a journey from the fundamental principles to advanced practical applications of ISO 13485, specifically tailored for the medical industry. Whether you’re a seasoned professional or new to the field, this course is designed to cater to all levels of expertise.

Key Highlights:


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  1. In-Depth Standard Understanding:
    • Gain a profound understanding of ISO 13485, covering normative references, definitions, and critical quality management principles that form the backbone of medical device quality assurance.
  2. Practical Implementation Techniques:
    • Acquire practical skills to implement quality assurance in medical device manufacturing. Learn how to ensure compliance with ISO 13485 through structured management, streamlined procedures, and accountability.
  3. Effective Documentation and Compliance:
    • Navigate the art of creating essential ISO 13485 documentation, including policies, objectives, manuals, procedures, work instructions, and record-keeping. Ensure effective compliance with industry standards.
  4. Thorough Quality System Audits:
    • Master the techniques of conducting comprehensive quality system audits! Covering matrix tracking, full audits, and management reviews, you’ll be well-prepared for ISO 13485 standards alignment and industry audits!

By the end of this course, you’ll not only have a solid theoretical understanding of ISO 13485 but also possess the practical skills needed to implement quality assurance effectively in the challenging landscape of medical device manufacturing.

Join us on this educational journey and elevate your expertise in ISO 13485 Quality Assurance!

English
language

Content

Introduction

Scope
APPLICATION

Terms and Definitions

Terms and Definitions

Quality Management System

GENERAL REQUIREMENTS
DOCUMENTATION REQUIREMENTS
QUALITY MANUAL
CONTROL OF DOCUMENTS
CONTROL OF RECORDS

Management Responsibility

MANAGEMENT COMMITMENT REQUIREMENTS
CUSTOMER FOCUS
QUALITY POLICY
PLANNING
RESPONSIBILITY, AUTHORITY, AND COMMUNICATION
MANAGEMENT REPRESENTATIVE
INTERNAL COMMUNICATION
MANAGEMENT REVIEW
REVIEW INPUT
REVIEW OUTPUT

Resource Management

PROVISION OF RESOURCES
HUMAN RESOURCE
COMPETENCE, AWARENESS, AND TRAINING
INFRASTRUCTURE
WORK ENVIRONMENT
Human Resources Health

Product Realization

PLANNING OF PRODUCT REALIZATION
VERIFICATION OF PRODUCT
CUSTOMER-RELATED PROCESSES
REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT REQUIREMENTS
CUSTOMER COMMUNICATION
DESIGN AND DEVELOPMENT
DESIGN AND DEVELOPMENT INPUTS
DESIGN AND DEVELOPMENT OUTPUTS
DESIGN AND DEVELOPMENT REVIEW
VERIFICATION REQUIREMENTS
DESIGN AND DEVELOPMENT VALIDATION
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
PURCHASING PROCESS
PURCHASING INFORMATION
VERIFICATION OF PURCHASED PRODUCT
PRODUCTION AND SERVICE PROVISION
THE USE OF MONITORING AND MEASURING DEVICES
CONTROL OF PRODUCTION AND SERVICE
INSTALLATION ACTIVITIES
SERVICE DATA, INFORMATION, AND REPORT
PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES

MEASUREMENT, ANALYSIS, AND IMPROVEMENT

MEASUREMENT, ANALYSIS, AND IMPROVEMENTβ€”GENERAL
MONITORING AND MEASUREMENT
INTERNAL AUDIT