INTRODUCTION TO WORKING IN THE MEDICAL DEVICE INDUSTRY

Prepare yourself for working in the medical device industry with this introductory, self-paced online course.

Introduction to Working in the Medical Device Industry - Online course feature image
Online course
From € 99/ seat

See pricing plan

Course lengthapprox. 4-11 hours
(8 CPD points)

Prepare yourself for working in the medical device industry with this introductory, self-paced online course.

Introduction to Working in the Medical Device Industry - Online course feature image

ONLINE COURSE

Course length3-6 hours
Course fee
(per person)
from € 99
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

YOU ARE HERE

€ 99​

Checkmark MDHQ  Average completion time​  4-11 hours

Checkmark MDHQ  Total video duration​ 2 hours

Checkmark MDHQ  CPD points 8

Checkmark MDHQ  Number of quizzes​ 19

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Digital course companion

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  6 months access to the course

ONLINE LIFETIME

€ 124 ​

Checkmark MDHQ  Average completion time​  4-11 hours

Checkmark MDHQ  Total video duration​ 2 hours

Checkmark MDHQ  CPD points 8

Checkmark MDHQ  Number of quizzes​ 19

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Digital course companion

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

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.
CPD points
This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training. Learn more
Number of quizzes
This is the total number of quizzes 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 personal 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.

You're here

€ 99
4-11 hours
2 hours
8 CPD points
19
6 months access
€ 124
4-11 hours
2 hours
8 CPD points
19
Lifetime

Contact us

Tailored training to meet your company’s needs

Course overview

This online course has been designed to make it easier for you to begin working in the medical device industry. It will provide you with a general understanding of the industry including key concepts and terminology.

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, and many other important areas.

It is suitable for anyone planning to, or has just started working with medical devices and wants to gain some insight into the regulatory world and get up to speed faster in their new role.

The course is made up of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate upon successful completion of the course.

If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).

Are you a hiring manager?

Make sure your new employees attend this course as part of their onboarding.

Benefits for you

Checkmark MDHQ Enhance confidence in medical device concepts

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 you will communicate with peers more effectively. You will be able to add value in meetings sooner and avoid doing something that results in undesirable nonconformities.

Checkmark MDHQ 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.

Checkmark MDHQ Environmentally friendly and efficient

By choosing our online courses, you contribute to a sustainable future. You eliminate the need to travel or create CO2 emissions associated with attending in-person training. With thousands of professionals trained each year, our online courses have saved substantial time and emissions, enabling efficient and environmentally conscious learning.

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 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.

Course modules​

NOTE – The course program structure is subject to change
  • Download your digital course companion
  • Welcome
  • What you need to know
  • Set your goal completion date
  • Pre-course assessment
  • What is a medical device?
  • Medical device terminology
  • The regulatory background
  • Standards
  • Introduction to audits
  • Quality concepts and audits – Part 1
  • Quality concepts and what to say – Part 2
  • Unannounced audits
  • What is a complaint?
  • The product development process – Part 1
  • The product development process – Part 2
  • Product documentation
  • Introduction to risk management
  • Introduction to usability engineering
  • Keeping things clean and functional
  • Product approval EU
  • Product approval US
  • Post market surveillance
  • Course evaluation

Frequently asked questions

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.

All in all, the average time to complete the course is 4-11 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.

If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply)

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.

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!

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.

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.

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

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.

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 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.
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.
There are no pre-requisites for this course.

Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.

A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.

As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.

Upon completion of the course, you are awarded 8 CPD points.

Your course certificate will display the exact number of CPD points. Read more.

Reviews

Group purchase

If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.

If you purchase three seats or more on the same online course 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.

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IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?

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Multiple seats

IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?

Oops, I actually wanted to buy seats for several people. Take me to the right place.

New Process validation for medical devices course!

Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.