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Master ISO 13485 – Quality Management for Medical Devices
Learn how to implement and manage a compliant quality management system (QMS) – and prepare for audits with ISO 13485
149,00€
4h video training 100 pages training material 60 days access (Single license)
What you'll learn
- Understand the full ISO 13485 structure and requirements
- Learn how to build and maintain a compliant QMS
- Understand management responsibility and quality processes
- Apply resource and competence management effectively
- Learn how product realization is structured in medical projects
- Understand measurement, analysis, and continuous improvement
- Prepare for audits and regulatory inspections
- Avoid common compliance mistakes in real companies
Course Preview: Get a Real Insight into the Training
Description
Medical device companies must operate under strict regulatory requirements. ISO 13485 defines the quality management system (QMS) needed to ensure consistent product quality and compliance.
This course provides a practical introduction to ISO 13485 and explains how quality management is implemented in real-world organizations. You will learn how companies structure their processes, manage responsibilities, and ensure compliance with regulatory expectations.
Instead of focusing only on theory, this course shows how the QMS is applied across the entire product lifecycle – from management responsibility to product realization and continuous improvement.
You will also understand how organizations prepare for audits and maintain compliance with standards such as EU MDR and FDA requirements.
By the end of this course, you will understand how ISO 13485 works in practice and how to apply it within your own organization.
Course content
Introduction
- Introduction & Agenda
- Motivation
Basics
- Overview of ISO 13485
- Structure of the standard
- QMS fundamentals
Quality Management System
- QMS structure and documentation
- Process-based approach
Management Responsibility
- Roles and responsibilities
- Management review
- Quality policy and objectives
Resource Management
- Personnel competence
- Training and awareness
- Infrastructure and work environment
Product Realization
- Planning and development
- Design and development processes
- Supplier management
- Production and service provision
Measurement, Analysis & Improvement
- Monitoring and measurement
- Internal audits
- CAPA (Corrective and Preventive Actions)
- Continuous improvement
Trusted by 12,000+ Engineers
From 100+ Countries
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Veselina Demireva
“The course is very structured and is based on the chapters of ISO 21434, which helped me a lot to compare the content of the course with the standard. This course is highly recommended for an initial overview of ISO. The content is clearly explained and easy to understand.”
Markus Simon
“The course has broken down a rather tough topic into a simpler words by connecting the right dots.“
Priyanka Pacharne
“Amazing, above expectations!“
Asfiyan Ali Khan
“I am coming to this program with 20+ years of experience with MIL-STD-882. This class allowed me to see what I would need to change in order to transition from 882 to ISO 26262. Overall, I thought this was a good presentation. I think the class provides a good overview for both the novice safety engineer and the old and crusty veteran. The class brought out many topics that forced me to go back to my old standard”
Patrick Norris
“Over all the course was really amazing with usefull information”
Prashanth Chotu
Looking for a complete medical device training?
Get access to all essential medical device standards in one structured learning path – from risk management to quality and software compliance
Build a solid foundation in medical device development by combining risk management, quality management, and software standards in one training.
This bundle includes:
- ISO 14971 – Risk Management for Medical Devices
- ISO 13485 – Quality Management Systems
- IEC 62304 – Medical Device Software
Medical Devices Engineering Bundle – All Courses in One
Build a complete understanding of medical device regulations and standards – and apply them in real projects
447,00€ 249,00€
Save 44%
✔ 8+ hours of video training
✔ 200+ pages of training material
✔ 60 days access (Single license)
✔ Practical examples and real-world use cases
✔ Quizzes and structured learning path