Introduction to Implementing and Maintaining a QMS for Medical Devices

ONLINE COURSE - COMING SOON

Learn how to implement and maintain Quality Management Systems (QMS) in medical device organisations during this self-paced, interactive online course.

Introduction to Implementing and Maintaining a QMS for Medical Devices online course

ONLINE COURSE

Course length10-15 hours
Course fee
(per person)
€ 299

Course description

This self-paced online course is designed for professionals responsible for implementing and maintaining Quality Management Systems (QMS) in medical device organisations. 

Participants will learn how to confidently define processes and write procedures and templates that comply with various norms and standards, such as ISO 13485, Quality System Regulation (QSR), the Medical Device Regulation (MDR), and In-Vitro Diagnostic Medical Device Regulation (IVDR).

Please note, the course does not include all the requirements of the ISO 13485, QSR, MDR or IVDR, but assumes you have background knowledge about the norms. 

The course is relevant for people engaged in authoring, reviewing, and approving procedures, for example process owners and QA staff.

The online course is made up of pre-recorded videos, quizzes, and a final exam. If you complete the final exam within 6 months of enrolment, you will have life-time access to the course (conditions apply ). 

You will be able to download a course companion within the online course and will receive a course certificate upon completion of the course.

Medical Device HQ is a member of the Swedish standardisation committee TK355 developing standards such as ISO 13485, ISO 14971 and IEC 62366-1. Peter Sebelius has partaken in authoring all of the above standards at an international level.

Sis standard developer 2024 certification
Peter Sebelius instructor

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 having implemented multiple quality management systems throughout his career.

Benefits for you

Checkmark MDHQ Emphasis on implementation of requirements

While many courses focus solely on explaining the requirements, this course go a step further by guiding you on how to actually implement them.

It is specifically designed to equip you with practical knowledge and strategies for meeting those requirements effectively.

Therefore by the end of the course you’ll not only understand the requirements but how to turn them into processes, procedures and templates.

Checkmark MDHQ Learn from an expert who authors the standards

The course creator is part of the standardization committee who authors the standard. This means you will be receiving up to the minute, first hand information and insights.

Learn from an industry leader’s expertise, experiences and shared best practices.

At the end of the course you’ll receive a course certificate to prove your competence.

Checkmark MDHQ Self-paced learning with life-time access

Our self-paced online course can be taken at your own pace. This means you can stop, repeat and resume as many times as you like, providing you with the flexibility to learn how and when you want.

If you complete the final exam within 6 months of enrolment, you will have life-time access to the course (conditions apply). If you do not, your course access will expire after 6 months.

Apply to become a validator for this course

  • If you are interested in becoming a validator on this online course, please fill in the form and we will get back to you.
  • When you submit this form, you will be sending personal information to medicaldevicehq.com. To comply with GDPR requirements, we need your consent to store and use the personal data you submit. Your personal data will be used in our customer relationship management system and our ticket system. We will not send you unsolicited emails.
  • Please press the REGISTER button. If you have any questions, don't hesitate to contact us!

Course programme

Frequently asked questions

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.
All in all, the average time to complete the course is 8-16 hours. 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.

If you complete the final exam within 6 months of enrolment, you will have life-time access to the course (conditions apply). If you do not, your course access will expire after 6 months.

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.
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!
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.

Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form

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

If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.

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.

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.

There are no pre-requisites for this course.

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SCHEDULED MAINTENANCE

Important! Please be advised that there will be scheduled downtime across our platforms from 13:00 CET Apr 26th to no later than 16.00 CET Apr 28th. During this period you will not be able to access the website or your account. For more information, please contact us at support@medicaldevicehq.com