DESIGN CONTROL FOR MEDICAL DEVICES

BLENDED COURSE: ONLINE COURSE + LIVE VIRTUAL CLASSROOM SESSION

Learn about the big picture and become more confident in applying design control for medical devices with the personal guidance of an industry expert.

This cutting-edge blended course focuses on how to develop new medical devices and maintain them in an organisation where design control requirements apply. It covers both the EU and US requirements. You learn the theory first during the online course, and then apply that theory during the live virtual classroom session(s).

BLENDED COURSE

Course length approx.
17-27 hours
Next classroom sessions
20 – 21 Oct 2021
1PM – 5PM CET – FULL

30 Nov 2021
9AM-4:30PM CET
Course fee
(per person)
€ 899

Course description

This course consists of two parts:

  1. The Introduction to Design Control for Medical Devices online course
  2. A live virtual classroom session held by the course creator

First, you complete the popular introductory design control online course. It covers topics such as the product development process, user needs and design input, design verification and design validation, design transfer, introductions to risk management, and usability engineering.

You can start the online course immediately and have access to it for 6 months, but you must successfully complete the final exam prior to the classroom session. If you have already completed the online course, you can register for the classroom session only.

The unique, highly interactive live virtual classroom session is facilitated by Peter Sebelius, who is an authority in this field. During the session, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn firsthand from an industry expert.

A printed course companion is included, as well as time-saving templates on how to implement design control effectively and efficiently.

We recommend this course to those who are new in the field, but also to the professionals involved in the development of medical devices, such as quality assurance, project management, and design engineering, or those involved in R&D and product development teams.

Want to know more about our blended courses? Watch the video below. 

Our blended learning courses combine the best of both worlds: online training and a live virtual classroom session(s) afterwards.

The online training allows for the flexibility in the way you learn, so that you can learn in a way which 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 would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.

The classroom session is highly interactive and focuses on applying the theory you have learnt during the online course 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

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

 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. This course is very pragmatic in its approach, and it covers both how to find and interpret requirements as well as how to implement them. 

 Get the big picture 

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

 Blended learning combines the best of both worlds 

You get to learn the theory at your own pace, during the online course, before applying the theory to practice with the guidance of an industry expert. You can get started on the online course right after registration and invoicing. 

 Course certificate 

Auditors may look for evidence that you are competent in design control. You will receive a course certificate after the successful completion of the course, which you can show the auditors if they ask. 

Course structure 

Blended course structure online + live virtual class

Online course

The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. You have the access to the online course for 6 months. It is self-paced and flexible in that you can start, stop, and repeat as much as you like. When you have finished the online course, you will be taking the final exam.

The Introduction to Design Control for Medical Devices online course consists of 18 lessons which are outlined below. 

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. Final exam
  • Final exam
Lesson 17. Course evaluation
  • Course Evaluation
Lesson 18. Classroom session info, case study & more!
  • Learn more in a live virtual class
  • The live virtual class product
  • Get your questions answered on the live virtual class

Classroom session(s)

You will attend this 1-day or 2 half-day live virtual instructor-led classroom session(s) via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are reallife case scenarios to work through, and plenty of time for discussions and questions. 

The live virtual class will cover the product development process and design control, how to write requirements, and the most common pitfalls in medical device development, as well as how to avoid them. 

The maximum number of people in a classroom session is 8.  

Included is a printed course companion and the following time-saving templates: 

  • Design and development plan template  
  • Design review template 
  • Intended use and use specification template 
  • Requirement traceability matrix template 
  • Verification specification template
  • Standard search report
  • Design and development SOP

Frequently asked questions

Is the course a live webinar?

The blended course consists of two parts: the online course, and a live virtual classroom session.

The online course is made up of carefully scripted pre-recorded videos in order to maximise 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 the other 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.

How long does it take to complete the course?

The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 10-20 hours to finish on average.

You do not 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, or 2 half-days, and lasts approximately for 7 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 for one person, we do. Use the contact form to request a quote for 3 or more participants. Please note, if there are more than 5 people from your organisation that should take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.

How long will I have access to the course?

You will have access to the online course for six months.

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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?

There is no pass/fail score on the exam as such, but you are 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 model of 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 if I have already completed the online course and taken the final exam?

If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom session, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.

You will need to retake the final exam by 3pm CET the day before the classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom session.

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 courses. 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 do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.

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

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