ISO 13485 2016 Course: Quality Management System for Medical Devices

ISO 13485 Online Training

Feeling overwhelmed by ISO 13485? You’re not alone—but we’re here to make it simple! Our video tutorials break down ISO 13485:2016 into easy-to-follow, practical steps. Think of this course as a helpful conversation—not a regulatory lecture. No complex language, no stress—just straight-to-the-point guidance that helps you understand how to build a quality management system that truly works for medical device development and manufacturing.

Whether you’re starting from scratch, preparing for certification, or refreshing your knowledge, we’ll guide you every step of the way.

Let’s make ISO 13485 your blueprint for quality, compliance, and patient safety. Ready? Let’s go!

ISO 13485 Online Training Requirements

• Technical Requirements: All you need is a stable internet connection, audio (headphones or speakers), and a modern web browser.
• Course Materials: You’ll get access to downloadable ISO 13485 templates, checklists, quality manual samples, and process mapping tools—everything you need, all in one place.
• Time Commitment: The course takes about three to five hours, and you can learn at your own pace, whenever it works for you.

ISO 13485 Online Training Target  Audience

• Quality Assurance and Regulatory Affairs Professionals

• Medical Device Manufacturers and Designers

• Internal Auditors and Compliance Managers

• Production and Operations Leaders

• R&D and Engineering Teams

• Consultants and Trainers in the medical device industry

• Anyone involved in ISO 13485 implementation or certification

ISO 13485 Online Training Key Benefits

• Clear, Focused Content: We break the requirements down into practical, easy-to-understand segments with examples specific to the medical device sector.
• Interactive Learning: Each module includes quizzes and exercises to reinforce learning and help you apply ISO 13485 principles to your organization.
• Implementation Ready: You’ll walk away with tools, templates, and a clear understanding of how to build or improve your medical device QMS.

ISO 13485 Online Training Outline

Introduction to ISO 13485:2016

• Get a clear overview of the standard, its purpose in the medical device industry, and its relationship to global regulatory requirements like EU MDR and FDA QSR.

Clause 4: Quality Management System

• What You’ll Learn: How to define the scope of your QMS, manage documentation, and control records with traceability and accountability.

Clause 5: Management Responsibility

• What You’ll Learn: The role of leadership in establishing a quality policy, assigning responsibility, and reviewing QMS effectiveness.

Clause 6: Resource Management

• What You’ll Learn: Identify the infrastructure, environment, and personnel competencies needed to support safe and effective device production.

Clause 7: Product Realization

• What You’ll Learn: From design and development to purchasing and production, learn how to manage the entire product lifecycle within a compliant QMS.

Clause 8: Measurement, Analysis, and Improvement

• What You’ll Learn: How to monitor quality, conduct internal audits, analyze data, and drive continual improvement based on feedback and findings.