From € 299/ seat
| Course length | approx. 10-15 hours |
Are you looking to establish a robust Quality Management System (QMS) for an organisation working with medical devices? This course provides a practical and actionable approach to implementing and maintaining a QMS that ensures compliance and promotes efficiency.
Unlike lead auditor courses that focus on auditing, this course is designed for those who are involved in writing, reviewing, and approving QMS manuals, procedures, and policies.
Using ISO 13485 for examples, you will learn best practices, strategies, and tools to build a QMS that meets relevant standards while being adaptable to organisational needs. Whether you’re a QA professional or someone stepping into the world of medical device quality management, this course empowers you with the knowledge to confidently design and sustain a system that supports innovation, compliance, and growth.
The principles taught in this course are universally applicable to any management system standard or regulation within the medical device industry, including ISO 13485, ISO 27001, ISO 14001, ISO 9001, the MDR, IVDR, and QMSR. While the course does not delve into the specifics of each standard or regulation, it equips you with the competence to establish and maintain systems that comply with them. This makes it an ideal foundation for navigating the complex regulatory landscape and achieving operational excellence.
This online course is designed for professionals responsible for implementing and maintaining Quality Management Systems (QMS) in medical device organisations. . The training ensures that you can confidently define processes, write procedures, and templates that comply with various norms and standards, such as ISO 13485, the Quality System Regulation (QSR), Medical Device Regulation (MDR), and In-Vitro Diagnostic Medical Device Regulation (IVDR).
This course caters to individuals that are 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. You will receive a course certificate upon successful completion of the course.
If you complete the final exam within 6 months of enrolment, you will have lifetime access to the course (conditions apply).
You will be able to download a course companion within the online course and you will receive a course certificate upon completion of the course.
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 focused on how to turn the requirements into processes, procedures, and templates.
Learn from an expert who authors the standardsThe 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.
Emphasis on implementation of requirementsWhile 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.
Self-paced learning with life-time accessOur 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.
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.
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 10-15 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.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.