Free
Average completion time 1-2 hours
Total video duration 0.5 hours
Number of quizzes 5
Final exam
30 day access to the course
Digital course companion
YOU ARE HERE
€ 399
Average completion time 9 - 24 hours
Total video duration 6 hours
CPD points 17
Number of quizzes 35
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
Digital course companion
€ 499
Average completion time 9 - 24 hours
Total video duration 6 hours
CPD points 17
Number of quizzes 35
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
€ 999
Average completion time 16-31 hours
Total video duration 6 hours
CPD points 24
Number of quizzes 35
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
Classroom sessions (2 * 3.5 hours)
Templates
CONTACT US
Tailored training to meet your company's needs
Gain the knowledge and tools necessary to navigate the complexities of medical device development with this course bundle, priced at only €698 (€898 if bought separately). Both courses included in the bundle offer come with lifetime access.
This online course focuses on understanding the process of how to develop new medical devices and maintaining them in organisations where design control requirements apply.
The course mentions both European and US requirements and introduces tools on how to work successfully and efficiently with design control.
We recommend this course for those who are new in the field as well as professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.
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. There is also a downloadable course companion within the course.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).
Know why and how to work with design controlDesign control can be made incredibly abstract if the course content focuses too much on the intangible requirements instead of how to actually do the work.
This course provides an overview of how to find and interpret requirements as well as how to implement them with a lean and pragmatic approach, potentially saving you lots of time.
Self-paced and bite-sized learningOur interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information.
This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
Training effectiveness and record-keepingParticipants’ knowledge is assessed through pre-training quizzes and a final exam, enabling a true measure of the training’s effectiveness.
Furthermore, we provide records, including the final exam score and course certificate, to satisfy ISO 13485 requirements, ensuring compliance and accountability.
Peter Sebelius 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 developed, amongst other things, a mechanical chest compression device 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.
All in all, the average time to complete the course is 9-24 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.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply).
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, Android or Windows 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.
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.
There are no pre-requisites for this course.
Upon completing the course, you can claim 17 CPD hours (17 CPD points) for the online course, and 24 CPD hours for the blended course.
Your course certificate will display the earned CPD hours.
If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.
If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.