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Quality Management Systems for Medical Devices (ISO 13485:2016) Course & Certification
Professional
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Updated 2026
3 hours
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Each course includes:
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
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Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any legislative changes in GDP as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed to ensure that you comply with GDP legislation through the application of learning outcomes. The course is written by Louise Handy, who is a past chairperson of the Research Quality Association (RQA
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About
Quality Management Systems for Medical Devices (ISO 13485:2016) is a comprehensive program designed to provide professionals with a practical understanding of quality management principles and regulatory requirements applicable to the medical device industry. The course focuses on establishing, implementing, maintaining, and continually improving a Quality Management System (QMS) in accordance with ISO 13485:2016 and global medical device regulations.
This Quality Management Systems for Medical Devices (ISO 13485:2016) Course & Certification provides structured training on QMS requirements, documentation controls, management responsibilities, design and process controls, supplier management, risk-based approaches, internal auditing, CAPA, and continuous improvement. Upon completion, learners receive certification demonstrating competency in ISO 13485:2016 requirements and medical device quality management practices.
Who Should Enrol?
- Quality Assurance, Quality Management, and Compliance Professionals in the medical device industry.
- Regulatory Affairs, Manufacturing, Operations, and Supplier Quality Personnel.
- Medical Device Engineers, Product Development Teams, and Process Improvement Specialists.
- Internal Auditors, CAPA Coordinators, and Quality Systems Professionals.
- Entry-level professionals and consultants seeking ISO 13485:2016 certification and expertise in medical device quality management systems.
What you will learn
Understand ISO 13485:2016 requirements, scope, quality management principles, and their role in medical device regulatory compliance.
Learn how to implement and operate a QMS, including documentation control, management responsibility, design controls, process controls, and supplier management.
Develop expertise in monitoring QMS performance through internal audits, nonconformance management, CAPA systems, and effectiveness evaluations.
Gain knowledge of measurement, analysis, continual improvement, and practical application of ISO 13485 requirements within medical device organizations.
Course Syllabus
- Overview of ISO 13485:2016 requirements, scope, and regulatory relevance for medical devices, including alignment with global regulatory expectations.
- Implementation and operation of QMS processes, covering documentation control, management responsibility, design and process controls, supplier management, and risk-based thinking.
- Monitoring and measurement of QMS effectiveness, including internal audits, nonconformance management, CAPA, and continuous improvement activities.
- Evaluation of knowledge and understanding of ISO 13485:2016 requirements and practical QMS application.
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Frequently Asked Questions
This course is suitable for Quality Assurance, Regulatory Affairs, Manufacturing, Compliance, and Medical Device professionals involved in implementing or maintaining a Quality Management System.
No prior knowledge is required. The course starts with ISO 13485 fundamentals and progresses to practical implementation.
Yes. The course is aligned with ISO 13485:2016 and reflects expectations under EU MDR and global medical device regulatory frameworks.
Yes. ISO 13485 applies to all classes of medical devices, and the principles covered are relevant across the device lifecycle.
The course is delivered online and can be completed at your own pace.
Yes. A final assessment is included to evaluate understanding of ISO 13485:2016 requirements.
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