DESIGN CONTROL & REQUIREMENTS ENGINEERING COURSE BUNDLE
- Course bundle
- EU and US requirements
- Beginner - intermediate
What's included in the bundle
This specialised 2-course bundle will provide you with the knowledge and tools necessary to navigate the complexities of medical device development for only €698 (€898 if bought separately). Both courses come with lifetime access as part of the bundle offer.
Course price
€ 499 € 399
Course price
€ 399 € 299
The Design Control course will help you understand the process of developing and maintaining medical devices in an organisation where design control requirements apply and get the “big picture”. Whilst the Requirements Engineering course focuses on defining and documenting user needs and design input requirements effectively. The courses, taken together, address some very common mistakes and provide a medical device perspective on design control and requirements engineering that can take away a lot of confusion and frustration in this field.
To help you build your skills and experience whilst gaining maximum value for money we have created this 2-course bundle with lifetime access to the courses (conditions apply) for the special price of €698 (€898 if bought separately).
We strongly recommend you take the Design control course first as it is pre-requisite to have good knowledge and experience of design control prior to taking the Requirements engineering course.
The bundle is aimed at people who are:
- Involved in the development of medical devices such as quality assurance, project management, design engineering
- Part of R&D and product development teams
- Involved in collecting, writing, reviewing or approving medical device user needs or design input requirements
The courses consist of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate for each course upon completion.
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 has authored the latest versions of 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
Self-paced and bite-sized learning
Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information. This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
Lifetime access to the course
Once you enroll in our online course and successfully complete the final exam within six months, you gain lifetime access to the course materials. This means you can refer back to the course content whenever you need it, ensuring ongoing support and knowledge retention.
Comprehensive reference material
We provide downloadable PDF files of the course slides as comprehensive reference material. These electronic course companions can be easily accessed, saved, and printed, allowing you to refer back to specific topics and reinforce your understanding. Additionally, the PDF format enables you to take notes and personalize the material according to your learning preferences.
INTRODUCTION TO DESIGN CONTROL FOR MEDICAL DEVICES
This online course focuses on understanding the process of how to develop new medical devices and maintain them in organisations where design control requirements apply. By the end of the course you will understand the “big picture” and know how to find, interpret and implement design control requirements.
Course programme
- Welcome
- What you need to know
- Set your course goal completion date
- Pre-course assessment quiz
- Why design controls 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
- Final exam
- Course evaluation
Introduction to Medical Device Requirements Engineering
This online course will teach you how to define and document user needs and design inputs. By the end of the course you will not only be able to write effective requirements, but also manage them throughout the project lifecycle.
Course programme
- Download your course companion – Part 1
- Welcome
- What you need to know
- Set your course goal completion date
- Pre-course assessment quiz
- Why requirements – Part 1
- Why requirements – Part 2
- What are requirements and stakeholders?
- Definitions relating to requirements
- Design and development of medical devices
- Product development requirement types – Part 1
- Product development requirement types – Part 2
- Other types of requirements – Part 1
- Other types of requirements – Part 2
- The bucket principle
- The systems engineering overview – Part 1
- The systems engineering overview – Part 2
- Download the course companion – Part 2
- The requirements engineering process
- Tools for collecting requirements – Part 1
- Tools for collecting requirements – Part 2
- Tools for writing needs and requirements
- Which user needs to collect
- Conforming user needs
- Appropriate user needs
- Feasible user needs
- Able to be validated
- Consistent user needs – Part 1
- Consistent user needs – Part 2
- Acceptance criteria for user needs
- Download the course companion – Part 3
- Introduction to design inputs
- Transforming user needs to design input requirements
- Conforming design inputs
- Unambiguous design inputs – Part 1
- Unambiguous design inputs – Part 2
- Complete design inputs
- Singular design inputs
- Verifiable design inputs
- Acceptance criteria for design inputs
- Common mistakes – design inputs
- Requirements from standards
- Medical device traceability
- Risk control measures and design inputs
- Requirements change management
- Pre-final exam
- Final Exam
- Course Evaluation
Frequently asked questions
The courses are not webinars. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.
All in all, the average time to complete the 2-course bundle is 17-46 hours. We recommend you take one course at a time.
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 attempt at taking it.
On the condition that you complete the final exam within 6 months of enrolment, you will have lifetime access to the course (conditions apply). This applies to both courses.
The course certificates are available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find them under Your Course Certificates.
We offer a number of payment methods via checkout 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.
If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.
The instructor has conducted training in the field of medical device product development 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.
There are no pre-requisites for this 2-course bundle. However we recommend you take the Introduction to Design Control for Medical Devices online course first.
Group purchase
If you wish to purchase two or more licenses of the same bundle, click the ‘Buy multiple bundles’ button below which will take you to the product page where you can simply enter the number of bundles you require.
If you purchase three or more of the same bundle at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.