ISO 13485 Foundation Training
ISO 13485 Foundation Training is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).
Key Course Information
What you need to know?
Our industry-leading Online Training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Available Formats:
eLearning
Customized Learning
Learning Objectives
On completion of this course, successful Learners will have the knowledge needed to:
- Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
- Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
- Explain the specific quality management-related requirements of ISO 13485
Frequently Asked Questions
Reviews & Ratings
4.5
Average Rating
471 global ratings
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My experience with the ISO 13485 foundation course was excellent. The course content was well-structured and the platform user friendly. This course really enhanced my understanding of the material by providing extra information and examples.
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This is a very helpful course to understand ISO 13485 and be more confident in dealing with all the processes required in the QMS. Well structured course with plenty of additional information on the ISO.
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I thought the course was reasonably straightforward.
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I believe this course helped me understand the foundations of ISO 13485 and the objectives were very well defined.
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This was a great introductory course for ISO 13485:2016. It added a lot of information on what each section really means and requires. I found it hugely helpful how it showed which sections go together for certain areas of quality, verses just going in order and stating the standards verbatim. I also enjoyed all of the scenarios and examples.
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The course was well designed and thorough. It addressed all needed topics very well, and did not leave me with any significant questions. The additional resources were also very useful.
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The course is well designed and on successful completion leads to a very thorough understanding of the requirements of ISO 13485. This is very benefical for quality professionals who want to ensure that their companies quality management system remains compliant.
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Excellent content and I enjoyed the narration
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The Comply Guru course is well organized. The interactivity is a good feature.
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I failed the end exam twice both times achieving 65%. I expected the second exam to be the same exam as the first one but almost all questions were different . I had to study the whole course again to ensure that I passed. (95%). Great course