INTRODUCTION TO QUALITY MANAGEMENT FOR MEDICAL DEVICES AND ISO 13485

ONLINE COURSE

Learn about quality management and the requirements of ISO 13485 during this self-paced, interactive online course.

Quality Management for Medical Devices and ISO 13485

ONLINE COURSE

Course length 10-15 hours
Course fee
(per person)
€ 299

Purchase the course access for single user:

Purchase the course access for a group of users:

Course description

This online course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management systems.
Topics covered on the course include: the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization & traceability.
It is relevant for people working with QA related tasks in a medical device organisation (including authoring, reviewing and approving procedures) and those who are typically engaged in supporting QA related tasks such as CAPA, complaints, risk management, documentation and internal auditing.
The online course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course.
Peter Sebelius - instructor portrait

Peter Sebelius (PMP) is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience too having developed, amongst other things, a mechanical chest compression and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

Benefits for you

 Make quality management more tangible

We have designed this course to be as pragmatic as possible in order to make quality management more tangible. There are real life examples and quiz questions to test understanding throughout. You will learn what you need to do, why and how.

Understand the meaning of the requirements in the standard

Reading the ISO 13485 standard is easy (albeit not particularly entertaining), but understanding the meaning of the requirements and how to implement them in an effective way is much harder. This course gives you the keys to unlock the meaning of the requirements and the ways you need to work operationally to meet the requirements.

 Self-paced learning

You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.

Course Programme

0 Base Course
Lesson 1. Introduction
  • Welcome
  • What you need to know
  • Set your course completion date
  • Pre-course assessment quiz
  • What is quality management and why it is important
  • The regulations and standard
Lesson 2. Quality management fundamentals
  • What is a quality management system?
  • Shall or should
  • The structure of the QMS
  • Processes, policies and procedures
  • Maintaining the QMS
Lesson 3. The ISO 13485 standard
  • Which standard should you use?
  • Getting to know the ISO 13485
Lesson 4. Risk management
  • Risk management and ISO 13485
Lesson 5. Audits
  • ISO 13485 stakeholders
  • Different types of audits
  • ISO 13485 internal audit requirements
Lesson 6. Control of documents and records
  • Documents and records
  • Establish and implement a new document
  • Update and maintain a document
  • Control of records
Lesson 7. Management responsibility
  • Quality policy and objectives
  • Management review
Lesson 8. Resource management
  • Human resources
  • Responsibility and authority
  • Infrastructure and work environment
Lesson 9. Customer related processes
  • Selling a medical device
0 Base Course
Lesson 10. Design and development
  • Design and development and projects
  • Design and development planning
  • Design and Development inputs
  • Design and development outputs
  • Verification and validation
  • Design and development transfer
  • Design and development review
  • Product documentation
Lesson 11. Purchasing
  • Purchasing
Lesson 12. Production and service
  • Production (part 1)
  • Production (part 2)
  • Process validation
  • Measuring equipment and calibration
  • Nonconforming products
Lesson 13. Design and development changes
  • Design and development changes
Lesson 14. Improvements
  • Feedback and data analysis
  • CAPA
Lesson 15. Complaints
  • Complaints
Lesson 16. Final exam
  • Final exam
Lesson 17. Course Evaluation
  • Course evaluation

NOTE – The course program structure is subject to change

Frequently asked questions

Is the course a live webinar?
The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.
How long does it take to complete the course?

All in all, the average time to complete the course is 10-15 hours, but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes. Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is the final exam, where you will only have one shot.

How long will I have access to the course?
You will have access to the course for six months.
What if I lose internet connection during the final exam?

You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.

Can I fail the final exam?
There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
Where can I find my course certificate?

The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.

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What payment methods will you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.

Can I view the course on a mobile device?

Yes, you can. The course is in HTML5 format which will play on any new iOS or Android devices.

Do you offer volume discounts?

If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.

Can a colleague and I take the course at the same time?
The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.
Is the instructor accredited or certified to give this training?

There is no certification or accreditation for quality management, however the instructor has conducted training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.

What are the pre-requisites for this course?
There are no pre-requisites for this course.

Group purchase

You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.

For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.

With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.

Still haven’t decided?

Get in touch with us and get more information:

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