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.

Online course +
2 Live classroom sessions

€ 899/ seat

Cancellation policy

Course lengthapprox. 19-25 hours
Next classroom sessions

18-19 Jun 2024 – FULL
1PM-4:30PM CET

11-12 Sep 2024
1PM-4:30PM CET

Select your course plan

QUICKSTART

Free

Checkmark MDHQ  Average completion time​  1-2 hours

Checkmark MDHQ  Total video duration​ 37 minutes

Checkmark MDHQ  Number of quizzes​ 5

Checkmark MDHQ  Final exam​

Checkmark MDHQ  60 day access to the course 

Checkmark MDHQ  Digital course companion

 

ONLINE

€ 299​

Checkmark MDHQ  Average completion time​  10-12 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  Number of quizzes​ 35

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ 6 months access to the course and instructor

Checkmark MDHQ  Digital course companion

ONLINE LIFETIME

€ 399 ​

Checkmark MDHQ  Average completion time​  10-12 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  Number of quizzes​ 35

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

Checkmark MDHQ  Digital course companion

BLENDED

YOU ARE HERE

€ 899 ​

Checkmark MDHQ  Average completion time​  17-19 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  Number of quizzes​ 35

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Lifetime access to the course and instructor

Checkmark MDHQ  Digital course companion

Checkmark MDHQ  Classroom sessions (2 * 3.5 hours)

Checkmark MDHQ  Templates

IN-HOUSE TRAINING​

CONTACT US​

Tailored training to meet your company's needs

Average completion time
The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam.
Total video duration
This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension.
Number of quizzes
This is the total number of quiz questions in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers.
Course access
Lifetime access to the online course is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes.
Final exam
The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record.
Digital course companion
The digital course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts.
Course certificate
Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued.
Ask the instructor
Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments.
Classroom sessions (2 * 3.5 h)
The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting.
Templates
Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations.
Free
1-2 hours
37 minutes
5
60 days
€ 299
12-18 hours
5.5 hours
35
6 months access
€ 399
12-18 hours
5.5 hours
35
Lifetime access
You're here
€ 899
19-25 hours
5.5 hours
35
Lifetime access
Contact us
Tailored training to meet your company’s needs

Course overview

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 after enrolment and 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 downloadable course companion and time-saving templates are included in the blended course.

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.

Medical Device HQ is a member of the Swedish standardisation committee TK355 developing standards such as ISO 13485, ISO 14971 and IEC 62366-1. Peter Sebelius has partaken in authoring all of the above standards at an international level.

Sis standard developer 2024 certification

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 instructor

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.

medical device hq instructors - Helena Hjälmefjord

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

Checkmark MDHQ Learn how to do practical 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.

Checkmark MDHQ Comprehensive reference material 

We understand the importance of retaining knowledge beyond the course duration. That’s why we provide a digital course companion of key concepts accompanied by relevant images and helpful flowcharts. 

The PDF format enables you to take notes and personalize the material according to your learning preferences. 

Checkmark MDHQ Interactive instructor engagement 

Our instructors are passionate about what they do, bringing their expertise and love for the subject into the learning experience.

Participate in active learning by asking questions directly to the instructor, taking part in group workshops and discussions. This allows you to seek clarification, share insights, apply and transfer knowledge.

Course structure

Blended learning journey v3

Online course

The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. It is self-paced and flexible so that you can start, stop, and repeat as much as you like. You will have lifetime access to the online course (conditions apply)

The Introduction to Design Control for Medical Devices online course consists of 20 lessons which are outlined below.

  • 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
  • The most essential requirements
  • Why standards?
  • The names and numbers of standards
  • Areas covered by standards
  • Medical device product classification
  • Product approval
  • Introduction to design and development inputs
  • The V model and requirement traceability
  • The systems engineering overview
  • How to write requirements – Part 1
  • How to write requirements – Part 2
  • How to manage requirements – Part 1
  • How to manage requirements – Part 2
  • Risk management – an introduction
  • Usability engineering – an introduction
  • Why planning?
  • The design and project plans
  • Other plans and requirements
  • Design review
  • Design and design outputs
  • What is design transfer?
  • Process validation
  • The V & V process
  • Verification planning
  • Verification methods and validation
  • Selecting verification methods
  • The verification protocols
  • Executing verification
  • Scheduling V & V
  • Design validation – Part 1
  • Design validation – Part 2
  • Change control
  • How it all fits together – Part 1
  • How it all fits together – Part 2
  • Pre-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.

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

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

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.

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 receive 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 another course certificate covering both the online course and the classroom session by email.

If you wish to buy 3 or more seats, we invite you to reach out using the contact form to discuss discount options. Please note, if there are more than 5 people from your organisation wising to take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.

If you complete the final exam within 6 months of enrolment, you will have lifetime access to the online course (conditions apply). If you do not, your course access will expire after 6 months.

Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.

The maximum number of participants for the live virtual classroom session is 8.

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 are no pre-requisites for this course.

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.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form

Testimonials

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.

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