SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Quality Management Systems for Medical Devices (ISO 13485:2016)
4.7
★★★★★
97% Recommended
Updated 2025
3 hours
8 active users
3 points
Your Study Basket
1 x Quality Management Systems for Medical Devices (ISO 13485:2016)
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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.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
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
This course offers a detailed explanation of the QMS for Medical Devices (ISO 13485:2016), focusing on the key regulatory changes, responsibilities of manufacturers and stakeholders, documentation requirements, and conformity assessment routes. It is suitable for individuals involved in regulatory affairs, quality assurance, clinical evaluation, medical device development, and compliance functions.
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.
