INTRODUCTION TO DESIGN CONTROL FOR MEDICAL DEVICES (ONLINE)

Course Information

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.

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.

Self-paced learning

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.

Curriculum 

Lesson 0. Start
Lesson 1. Introduction
  • Welcome
  • What you need to know
  • 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
  • User needs and design input
  • The V model and requirement traceability
  • How to write requirements
Lesson 5. Design and development inputs
  • User needs and design input
  • The V model and requirement traceability
  • How to write requirements
Lesson 6. Design planning
  • Why planning
  • The design and project plans
  • Other plans and requirements
Lesson 7. Design review
  • Design review
Lesson 8. Design phase and design output
  • Design and design outputs
  • Process and product requirements
Lesson 9. Design transfer
  • What is design transfer?
Lesson 10. Design verification and validation
  • From design input to end
  • Before you start verification
  • Methods and validation
Lesson 11. Change control
  • Change control
Lesson 12. Final Exam
  • Final Exam
Lesson 13. Course Evaluation
  • Course Evaluation

Testimonials

I would highly recommend this Design Control online course for colleagues in the medical device industry. Peter is a very motivational and inspiring presenter who engages you with his pragmatic approach and ability to break down a complex subject into more simple, clear, manageable chunks. This was a great learning experience and one of the best online courses I have ever participated in.

Claus Rømer

Regulatory Consultant, Rømer Consulting

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!

Xabier Hernandez

Technology Manager, iLine Microsystems

Course Category

ONLINE COURSE

Course Length
6-8 hours
Course Fee (per person)
€ 249

Frequently Asked Questions

Is the course a live webinar?

The course is not a webinar, but a pre-recorded course with video and audio. You can watch it as many times as you like, whenever you want and where ever you want. You can not download the course though, thus you will need to have 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 6-8 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 to register your result on the final exam. In the unfortunate event you have a computer problem that does not allow you to send the result of the final exam to our servers for any reason, we recommend you to capture the screen with your result using “Print screen” or any other screen capture. You can even photograph the screen. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should recieve 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 the lessons overview and expand the final exam. From there you can download a PDF version of your course certificate.

What payment methods will you accept?

You can pay using Visa, Mastercard or American Express. We can send you an invoice for the course if you wish. If this is the case, please go to the course registration page Add in link to course registration page here. Upon registration please inform us that you would like to be invoiced for the course. It will take longer to invoice for the course 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 or Android phone.

Do you offer volume discounts?

If you buy more than 10 seats, we do. Use the contact form to request a quote for more than 10 participants.

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.

Are you 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.