Medical Device Requirements Engineering
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - Mar 2026
Learn about writing medical device user needs and design input requirements in this self-paced, interactive online course.
We recommend that you take the design control course before this course unless you already have a good understanding of design control.
| Course length | approx. 8-22 hours (16 CPD points) |
Do you want this course on your internal LMS? Contact us
Select your course plan
SPECIAL OFFER
DESIGN CONTROL AND REQUIREMENTS ENGINEERING
COURSE BUNDLE FOR ONLY €698
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.
Course overview
This 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.
ONLINE
YOU ARE HERE
€ 399 € 299
Average completion time 8-22 hours
Total video duration 5.5 hours
Number of quizzes 28
CPD points 16
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
ONLINE LIFETIME
€ 499 € 399 Average completion time 8-22 hours
Total video duration 5.5 hours
CPD points 16
Number of quizzes 28
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
BLENDED
€ 999 € 899 Average completion time 15-29 hours
Total video duration 5.5 hours
CPD points 23
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 needs
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).
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
- 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.
Benefits for you
- Learn to define and document user needs and design inputs
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.
- Training effectiveness and record-keeping
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.
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.
Course modules
- Download your course companion – Part 1
- Welcome
- What you need to know
- Set your course goal completion date
- Pre-course assessment quiz
- Why requirements – Part 1
- Why requirements – Part 2
- What are requirements and stakeholders?
- Definitions relating to requirements
- Design and development of medical devices
- Product development requirement types – Part 1
- Product development requirement types – Part 2
- Other types of requirements – Part 1
- Other types of requirements – Part 2
- The bucket principle
- The systems engineering overview – Part 1
- The systems engineering overview – Part 2
- Download the course companion – Part 2
- The requirements engineering process
- Tools for collecting requirements – Part 1
- Tools for collecting requirements – Part 2
- Tools for writing needs and requirements
- Which user needs to collect
- Conforming user needs
- Appropriate user needs
- Feasible user needs
- Able to be validated
- Consistent user needs – Part 1
- Consistent user needs – Part 2
- Acceptance criteria for user needs
- Download the course companion – Part 3
- Introduction to design inputs
- Transforming user needs to design input requirements
- Conforming design inputs
- Unambiguous design inputs – Part 1
- Unambiguous design inputs – Part 2
- Complete design inputs
- Singular design inputs
- Verifiable design inputs
- Acceptance criteria for design inputs
- Common mistakes – design inputs
- Requirements from standards
- Medical device traceability
- Risk control measures and design inputs
- Requirements change management
- Pre-final exam
- Final Exam
- Course Evaluation
Do you want this course on your internal LMS? Contact us
Frequently asked questions
All in all, the average time to complete the course is 8-22 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.
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.
A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.
Upon completion of the course, you are awarded 16 CPD points for the online course and 23 CPD points for the blended course.
Your course certificate will display the exact number of CPD points. Read more.
Reviews
Agilent Technologies
CMR Surgical
iCare
Diagnostics Research and Product Development
Global Health Labs, Inc.
Quality Engineering - Software, BD
iCare
Phillips Medisize A/S
Novo Nordisk
Compliance Director
Vision RT
Group purchase
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.