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| Course length | 10-15 hours |
| Course fee (per person) | from € 299 |
ONLINE
YOU ARE HERE
€ 229
Average completion time 10-15 hours
Total video duration 5.5 hours
Number of quizzes 28
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
ONLINE LIFETIME
€ 399
Average completion time 10-15 hours
Total video duration 5.5 hours
Number of quizzes 28
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
BLENDED
€ 899
Average completion time 17-22 hours
Total video duration 5.5 hours
Number of quizzes 28
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Printed course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needsThis self-paced online course begins with an introduction to the fundamental concepts of requirements engineering and how they relate to medical device design. Participants will learn how to define user needs and translate them into design input requirements that meet the needs of patients, healthcare providers, regulators and other key stakeholders.
The course is designed for medical device engineers who want to gain a deep understanding of the principles and practices of requirements engineering. It is based on requirements engineering best practices, ISO 13485 and QSR requirements and it covers the entire process of requirements engineering from user needs to design input requirements. The course also covers the importance of traceability.
Participants will learn how to categorise requirements, manage changes to requirements, and ensure that requirements can be verified or validated.
The course is relevant for R&D engineers, systems/requirements engineers, usability engineers or people working in QA. If you are involved in collecting, writing, reviewing or approving medical device user needs or design input requirements, this course is for you.
The online course is made up of pre-recorded videos, quizzes, and a final exam. 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).
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.
Crafting clear and effective user needs and design inputs is a complex task, but it’s essential in successful medical device development. With a solid grasp of requirements, you can streamline the design process, saving valuable time and resources.
By the end of the course you will not only be able to write effective requirements, but also manage them throughout the project lifecycle.
Participants’ 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.
Our 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.
Gain the knowledge and tools necessary to navigate the complexities of medical device development with this course bundle, priced at only €598 (€798 if bought separately). Both courses included in the bundle offer come with lifetime access.
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 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.
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 via checkout 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.
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 instructor has conducted training in the field of medical device product development 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.
It is recommended to have taken the design control course before this course unless you already have a good understanding of design control.
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?
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.
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