Deep Dive: Quality Management and ISO 13485

Categories: Deep Dive, EU, FDA
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About Course

We are currently revising this course. The updated version is expected in December 2024.

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A Deep Dive into how to create and maintain a Quality Management System for medical devices in line with ISO 13485.

This course provides a comprehensive guide to cover all essential aspects of Quality Management Systems and ISO 13485. Each module focuses on a specific area of ISO 13485 requirements, with practical applications. We also explore regional specific requirements for quality management for a well-rounded learning experience.

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What Will You Learn?

  • Understand the fundamental principles and regulatory requirements of Quality Management Systems (QMS) specific to the medical device industry, including ISO 13485
  • Develop and implement a compliant QMS, including risk management, document control, and resource management, to ensure consistent product quality and regulatory compliance.
  • Plan and conduct internal audits, management reviews, and performance evaluations to identify nonconformities and opportunities for continual improvement.
  • Manage supplier relationships and control processes to ensure that all products and services meet regulatory and quality requirements.
  • Prepare for ISO 13485 certification, including understanding the audit process, responding to findings, and maintaining ongoing compliance with the standard

Course Content

Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

  • Welcome!
  • Instructor Tips
  • Course Scope

Quality Management Systems (QMS) and Medical Devices
Let's explore the role and importance of the QMS in medical device manufacturing

Introduction to ISO 13485
As the main standard for QMS, let's take some time to get familiar with ISO 13485

Context of the Organization

Leadership and Commitment

Planning of the QMS

Resourcing and Support

Operations

Performance Evaluation

Improvement
Corrective and Preventive Actions (CAPA)

ISO 13485 Certification Process and Best Practices

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