DESIGN CONTROL FOR MEDICAL DEVICES

ONLINE + LIVE VIRTUAL CLASSROOM TRAINING - BLENDED COURSE

This is a blended (online + live virtual classroom session) course focused on how to develop new medical devices and maintain them in organisations where design control requirements apply. The course covers both European and US requirements.

BLENDED COURSE

Course length approx.
14-20 hours
Next classroom session
8-9 Dec 2020
(course full)

26-27 Jan 2021
1PM- 5PM CET
Course fee (per person) € 899

Course description

This course focuses on understanding notified body- and FDA requirements on how to develop new medical devices and maintaining them in organizations where design control is a requirement.

The course includes tools and templates on how to implement design control effectively and efficiently.

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.

What is a blended course?

Our blended learning courses combine the best of two worlds. Online training is combined with live virtual classroom sessions. You get to learn the theory first at your own pace, during the online course, before applying theory in practice with the guidance of the expert instructor. 

The online training provides flexibility in how you learn so you can learn in a way that suits you best. You can access it whenever and wherever you want and you can stop, start and repeat the lessons and quizzes as often as you like. To help maximise your learning we assess your knowledge and understanding at the start and throughout the online training, culminating with a final exam at the end. 

The classroom session is highly interactive and focuses on applying the theory in practice with the guidance of the expert instructor. There are real life case scenarios to work through and plenty of time for discussions and questions!  

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.

Benefits for you

 Blended learning combines the best of both worlds

You get to learn the theory at your own pace, during the online course, prior to applying the theory into practice with the guidance of an industry expert.

Understand why and how to work with design control

Design control can be made incredibly abstract if there is too much focus on the intangible requirements instead of how to actually do the work. The course is very pragmatic in its approach and covers both how to find and interpret requirements, as well as how to implement.

Start right away

You can get started on the online course after registration and invoicing.

You get the big picture

You get a clear overview of the product development process, from feasibility to phase out of the product. Knowing where you are in the process is key to making the right next moves in design control.

Course programme

This blended course is done in two parts: an online course with a final exam and a classroom session.

Online course structure

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. 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
  • Why planning
  • The design and project plans
  • Other plans and requirements
Lesson 8. Usability engineering
  • Usability engineering
Lesson 9. Design planning
  • Why planning
  • The design and project plans
  • Other plans and requirements
Lesson 0. Start
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. Pre-classroom survey
  • Course Evaluation
Lesson 17. Final exam
  • Final exam
Lesson 18. Course evaluation
  • Course Evaluation

Classroom session

1-day live virtual instructor-led classroom session working on case studies & real-life scenarios.

Frequently asked questions

Is the course a live webinar?

The blended course comprises two parts: the online course and a live virtual classroom session.

The online course is made up of carefully scripted pre-recorded videos to maximize your learning. The live virtual classroom session is a virtual face-to-face 1-day session where you will be interacting with the instructor and course participants via Zoom. You are required to be visible on video when taking the classroom session.

Can I view the online 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.

How long does it take to complete the course?

All in all, the average time to complete the blended course is 14-20 hours. The online course takes approximately 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 live virtual classroom is a 1-day session and lasts approximately 8 hours.

Where can I find my course certificate?
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to My Courses, and scroll down. You will find it under Your course certificates.

After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.

Do you offer volume discounts?
If you buy more 3 or more seats, we do. Use the contact form to request a quote for 3 or more participants.
How long will I have access to the course?
You will have access to the online course for six months.
What is the maximum number of participants in the live virtual classroom?
The maximum number of participants for the live virtual classroom session is 8.
Can I fail the final exam?
No, you cannot fail the final exam. However, it is required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good marker on what you will get on the final exam.

If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR and you can take it again.

What are the pre-requisites for this course?
There are no pre-requisites for this 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 payment methods will you accept?

After signing up on the course registration page, we will send you the invoice for the course. 

Testimonials

The course provided a very fulfilling insight into Design Control. The pre-course and test provided a good basis for understanding important principles to be able to follow the online course.
Peter is very knowledgeable and enlightened the course with great humor.
Pernille Amping

Senior Clinical Research Specialist , Ambu

This was a great course which provided an excellent overview as well as some helpful tools and techniques which will save me time back at work.
Cathrine Heuch

CEO, Nordic Brain Tech

Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course