INTRODUCTION TO WORKING IN THE MEDICAL DEVICE INDUSTRYONLINE COURSE
Prepare yourself for working in the medical device industry with this introductory, self-paced online course.
|Course length||3-6 hours|
Purchase the course access for yourself only:
Purchase the course access for a group of users:
This online course focuses on making it easier for you to start working in the medical device industry by providing you with a general understanding of the industry including key concepts and terminology.
It is suitable for anyone planning to, or has just started working with medical devices and wants to gain some insight into the industry and get up to speed faster in their new role.
Topics covered include: an introduction to medical devices, the Quality Management System, how to behave during audits, an introduction to risk management, design control and usability engineering, complaints and vigilance, how to behave in controlled environments including clean rooms, and many other important areas.
The course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course.
Are you a hiring manager?
Make sure your new employees attend this course as part of their onboarding.
In case you want to buy the course on someone else’s behalf:
Single seat course purchase is personal and linked to the user account and the email address of the person making the purchase.
If you wish to make the purchase for someone else, they will have to create a separate account, and go through the checkout process. If the participant does not have a suitable credit card, they may select to pay using direct bank transfer as payment method at the end of the checkout process.
Benefits for you
Avoid being mute in meetings
The goal is that upon completion of this course you will not only feel more confident in your ability to understand key medical device concepts and terminology but to communicate with peers more effectively. You will be able to add value in meetings sooner and avoid doing something that results in undesirable nonconformities.
Get information from the source
The instructor is an expert member of the technical committee TC 210 partaking in authoring several key standards for the medical device industry. If you are looking for a course to give you a good grounding in the medical device industry, make sure you choose a course where the instructor has first-hand information.
You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.
Peter Sebelius (PMP) 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 too having developed, amongst other things, a mechanical chest compression 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.
0 Base Course
Lesson 1. Introduction
- What you need to know
- Set your goal completion date
- Pre-course assessment
Lesson 2. The regulatory world
- What is a medical device?
- Medical device terminology
Lesson 3. Quality requirements
- The regulatory background
Lesson 4. Audits and inspections
- Introduction to audits
- Quality concepts and audits – Part 1
- Quality concepts and what to say – Part 2
- Unannounced audits
Lesson 5. Complaints and vigilance
- What is a complaint?
Lesson 6. Design control
- The product development process – Part 1
- The product development process – Part 2
- Product documentation
0 Base Course
Lesson 7. Risk management and usability
- Introduction to risk management
- Introduction to usability engineering
Lesson 8. Production and infrastructure
- Keeping things clean and functional
Lesson 9. Regulatory affairs
- Product approval EU
- Product approval US
Lesson 10. Post market surveillance
- Post market surveillance
Lesson 11. Final exam
- Final exam
Lesson 12. Course evaluation
- Course evaluation
NOTE – The course program structure is subject to change
Frequently asked questions
Is the course a live webinar?
The course is not a webinar. 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.
How long does it take to complete the course?
All in all, the average time to complete the course is 3-6 hours. 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 shot.
How long will I have access to the course?
You will have access to the course for six months.
What if I lose internet connection during the final exam?
You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.
Can I fail the final exam?
There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
Where can I find my course certificate?
The course certificate is 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 it under Your Course Certificates.
What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. You can select to pay by invoice instead of credit card at the end of the check-out process. Please note, if you would like to be invoiced, this will take longer and you may incur an invoicing fee.
Can I view the 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.
Do you offer volume discounts?
If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
Can a colleague and I take the course at the same time?
The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.
Is the instructor accredited or certified to give this training?
The instructor has conducted training in the field of medical devices for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971 and is a trained lead auditor on ISO 13845. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.
What are the pre-requisites for this course?
There are no pre-requisites for this course.
You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that the course access is linked to the email address, and the name you enter on checkout.
For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.
With a group purchase, when going through the checkout, you will receive group leader access which enables you to manage your group, including both adding and removing participants, and receiving progress reports and quiz reports.