DESIGN CONTROL FOR MEDICAL DEVICES
BLENDED COURSE: ONLINE COURSE + LIVE VIRTUAL CLASSROOM SESSIONS
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 two live virtual classroom sessions.
| Blended course | |||
|---|---|---|---|
|
Course length
|
|
|
approx.
17-27 hours |
|
Next classroom sessions
|
|
|
19-20 Apr 2023
1PM-4:30PM CET 7-8 Jun 2023 1PM-4:30PM CET |
|
Course fee
(per person) |
|
|
€ 899
Cancellation policy |
Course description
This course consists of two parts:
1. The Introduction to Design Control for Medical Devices online course
2. Two half day live virtual classroom sessions faciliated by an instructor
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 sessions. If you have already completed the online course, you can register for the classroom sessions only.
The unique, highly interactive live virtual classroom sessions are facilitated by Peter Sebelius or Helena Hjälmefjord. During the sessions, 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 first hand 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 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 two half-day live virtual classroom sessions 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 sessions are 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.
The instructors of the live virtual classes
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.
Helena Hjälmefjord has extensive experience within the medical device industry, Class I to Class III devicesand In-Vitro diagnostics;as well as with allografts (human tissue). Amongst others she has worked as project leader, quality manager as well as design control and regulatory assurance lead. Helena has worked in both small companies as well as large international companies. Since 2014 she works through her own consultant company, Fjord Consulting.
Helena’s motivation is getting customers to understand the importance and benefits of the regulations that are placed on their medical device products and related processes.
Benefits for you
Understand why and how to work with design control
Understand why and how to work with design controlDesign 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.
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.
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. 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
Online course
- 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
- Speaking design controlish
- Product documentaton
- The project process – Part 1
- The project process – Part 2
- Why document so much
- The most essential requirements
- User needs and design input
- The V model and requirement traceability
- How to write requirements
- Medical device product classification
- Product approval
- 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)
- Why planning
- The design and project plans
- Other plans and requirements
- Usability engineering
- Why planning
- The design and project plans
- Other plans and requirements
- Design review
- Design and design outputs
- Process and product requirements
- What is design transfer?
- Process validation
- From design input to end
- Before you start verification
- Methods and validation
- Change control
- How it all fits together – Part 1
- How it all fits together – Part 2
- Final exam
- Course Evaluation
- Learn more in a live virtual class
- The live virtual class product
- Get your questions answered on the live virtual class
Classroom sessions
You will attend these two half-day live virtual instructor-led classroom sessions 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 real–life case scenarios to work through, and plenty of time for discussions and questions.
The live virtual classes 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.
- 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
The blended course consists of two parts: the online course, and two half day live virtual classroom sessions.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are face-to-face sessions 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 sessions.
Yes, you can.
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 two half-day live virtual classroom sessions, take approximately 7 hours in total.
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.
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.
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, 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 first 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 sessions.
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.
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
Peter is very knowledgeable and enlightened the course with great humor."
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.