INTRODUCTION TO DESIGN CONTROL FOR MEDICAL DEVICES (ONLINE)ONLINE COURSE
Learn how to be effective in medical device product development during this self paced, interactive online course.
Take a look at our free short course on Design Control:
|Course length||6-12 hours|
|Course fee (per person)||€ 299|
Purchase the course access for yourself only:
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.
In case you want to buy the course on someone else’s behalf:
Single seat course purchase is personal and linked to the user account and the email address of the person making the purchase.
If you wish to make the purchase for someone else, they will have to create a separate account, and go through the checkout process. If the participant does not have a suitable credit card, they may select to pay using direct bank transfer as payment method at the end of the checkout process.
Benefits for you
Overview of the process
Knowing where you are in the process is key to making the right next moves. Many of our students come to the course saying that they looked for the perfect overview, and got it.
Know why and how to work with design control
Design 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. The course is an introduction, it provides an overview on how to find and interpret requirements as well as how to implement with a lean and pragmatic approach, potentially saving you lots of time.
You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.
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 is revising the 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.
Lesson 0. Start
Lesson 1. Introduction
- What you need to know
- Set your course goal completion date
- Pre-course assessment quiz
- Why design control and what is it?
- Agile, waterfall, project management and design control
- What is a Medical Device?
- The changing regulatory landscape
Lesson 2. The project process
- Speaking design controlish
- Product documentaton
- The project process – Part 1
- The project process – Part 2
Lesson 3. Where do all requirements come from?
- Why document so much
- The most essential requirements
Lesson 4. Standards and guidance documents
- Why standards?
- The names and numbers of standards
- Areas covered by standards
Lesson 5. Product approval and classification
- Medical device product classification
- Product approval
Lesson 6. Design and development inputs
- User needs and design input
- The V model and requirement traceability
- How to write requirements
- How to manage requirements (Part 1)
- How to manage requirements (Part 2)
Lesson 7. Risk management
- Introduction to risk management
Lesson 8. Usability engineering
- Usability engineering
Lesson 0. Start
Lesson 9. Design planning
- Why planning
- The design and project plans
- Other plans and requirements
Lesson 10. Design review
- Design review
Lesson 11. Design phase and design output
- Design and design outputs
- Process and product requirements
Lesson 12. Design transfer
- What is design transfer?
- Process validation
Lesson 13. Design verification and validation
- From design input to end
- Before you start verification
- Methods and validation
Lesson 14. Change control
- Change control
Lesson 15. How it all fits together
- How it all fits together – Part 1
- How it all fits together – Part 2
Lesson 16. Final Exam
- Final Exam
Lesson 17. Course Evaluation
- Course Evaluation
This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.
Frequently asked questions
Is the course a live webinar?
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.
How long does it take to complete the course?
All in all, the average time to complete the course is 6-12 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.
How long will I have access to the course?
You will have access to the course for six months.
What if I lose internet connection during the final exam?
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.
Can I fail the final exam?
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!
Where can I find my course certificate?
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.
What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. Reach out to us on firstname.lastname@example.org if you would like to be invoiced instead. Please note, if you would like to be invoiced, this will take longer and you will incur an invoicing fee.
Can I view the course on a mobile device?
Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
Do you offer volume discounts?
If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
Can a colleague and I take the course at the same time?
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.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for design control, however 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.
What are the pre-requisites for this course?
There are no pre-requisites for this course.
I really enjoyed this Design Control online course, it was very well designed and structured, with good quality videos and charts throughout. The concepts were clearly presented and repeated to ensure understanding and the continuous evaluations worked brilliantly. I would definitely recommend this course!
The course gave a magnificent overview of the necessary design controls needed to bring a product to market. I look forward to bringing my newly acquired knowledge back to my organisation.
You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that the course access is linked to the email address, and the name you enter on checkout.
For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.
With a group purchase, when going through the checkout, you will receive group leader access which enables you to manage your group, including both adding and removing participants, and receiving progress reports and quiz reports.