Press esc to close
Press esc to close
Fill out your contact details below and our training experts will be in touch.
If you wish to make any changes to your course, please log a ticket and choose the category ‘booking change’
Back to Course Information
The following topics will be taught during this course
Module 1: Introduction to ISO 13485:2016
Module 2: An Overview of ISO 13485:2016 Requirements
Module 3: Implementation Phases of the ISO 13485 Frameworks
Module 4: Conducting an ISO 13485 Certification Audit
Module 5: The relationship between ISO 13485 and ISO 9001
This course is intended for:
There are no prerequisites for this course.
The Knowledge Academy's ISO 13485 Foundation course introduces the updated 2016 version of the ISO 13485. This includes: "Medical Devices Quality Management Systems - Requirements for Regulatory Purposes” - The international reference standard for quality systems for medical device manufacturers in regulatory systems across the globe. During this training experience, delegates will learn the goals and objectives of ISO 13485 and how to implement and manage a Medical Devices Quality Management System (MDQMS). Topics will cover MDQMS policy, processes, performance measures, management commitment, management review, internal audit, and continual improvement. The course aims to ensure that upon completion, delegates will understand the features and functionality of MDQMS, and be able to recognise the connection between ISO 13485 and other standards and regulatory frameworks.
This training course includes:
ISO 13485 Foundation Exam
In order to complete this ISO 13485 Foundation training course, delegates will need to pass the associated examination. The exam is:
Why choose us
Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.
Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.
This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.
All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.
We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible
We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience
Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!
This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.
Our courses can be adapted to meet your individual project or business requirements regardless of scope.
Cut unnecessary costs and focus your entire budget on what really matters, the training.
This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.
Keep track of your employees’ progression and performance in your own workspace.
Course was run very smoothly, Richard our trainer was extremely knowledgeable and delivered the course in a succinct fashion with a twist of humour thrown in.
The course was great and the so was the trainer - brilliantly delivered and I would certainly recommend this course to my colleagues. Thanks to Richard for a great course and delivering it a tough environment virtually.
Richard was very knowledgeable and explained well
You won't find better value in the marketplace. If you do find a lower price, we will beat it.
Flexible delivery methods are available depending on your learning style.
Resources are included for a comprehensive learning experience.
"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"
Joshua Davies, Thames Water