INTRODUCTION TO CLINICAL INVESTIGATION FOR MEDICAL DEVICES AND ISO 14155

ONLINE COURSE

Learn how to optimise the planning and conduct for clinical investigation of medical devices during this self-paced, interactive online course.

Online course
Course length
approx.
10-15 hours
Course fee (per person)
€ 399
Purchase the course access for single user:
Purchase the course access for a group of users:

Course description

This online course focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

It specifies the scope of clinical investigations of medical devices and provides a detailed summary of the standard’s key provisions.

It examines some of the current challenges facing medical device manufacturers in conducting clinical investigations and provides some valuable recommendations and considerations when designing clinical investigations in the pre-market and post-market settings.

It also covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents.

The course is practical and suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.

The online 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 you will receive a course certificate upon successful completion of the course.

Maria Nyakern

Maria Nyåkern, Ph.D., is an inspiring teacher and consultant with a long experience in the medical device industry as a clinical research scientist and entrepreneur across the spectrum of early-stage start-ups to large multi-national organizations. She has vast ‘hands-on’ experience, having set up and managed dozens of clinical investigations, with tens of thousands of patients, for different medical devices and many of the industry’s top ten medical device manufacturers.

In 2017, Maria Nyåkern founded AKRN Scientific Consulting, a European medical device CRO. As CEO, she led a 50+ team of consultants supporting manufacturers in the regulatory and clinical development of medical device technology. AKRN Scientific Consulting was acquired by NAMSA in 2022, and Maria transitioned to Executive Director at NAMSA.

Maria Nyåkern is part of the ISO committee, SIS/TK 340 and ISO/TC 194 Biological and clinical evaluation of medical devices, responsible for developing the ISO 14155 standard. She is an experienced consultant in clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard.

Dr. Nyåkern is a Doctor of Cell Biology at Stockholm University, Sweden (2003) and a Postdoctoral Fellow at the University of Bologna, Italy (2006).

Benefits for you

Checkmark MDHQ Become confident in setting up clinical investigations

The goal is that upon completion of this course, you should understand the overall process of a clinical investigation and how to address good clinical practice (GCP) to assess the clinical performance or effectiveness, and safety of medical devices.

You should also be able to participate in the design and planning of a clinical investigation, the management and monitoring of clinical sites and subjects, and the recording and reporting of clinical data according to ISO 14155:2020.

Checkmark MDHQ Course certificate to prove to regulatory agencies and CROs you know your stuff

Auditors, sponsors, and possible employers will look for evidence that you are competent in GCP ISO 14155:2020. You will have a specific course certificate to bring up if you need to demonstrate your qualifications during an audit, a clinical strategy meeting, or a job interview. Show that you know your stuff and present this course certificate!

Checkmark MDHQ Self-paced learning

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.

Course programme

  • Welcome
  • What you need to know
  • Set your course completion date
  • Pre-course assessment quiz
  • Introduction to clinical research of medical devices
  • What is a medical device?
  • Clinical research of drugs vs devices
  • What is good clinical practice (GCP)?
  • Who must follow GCP?
  • ISO 14155 content, clauses, and annexes
  • Major changes in the new version ISO 14155:2020
  • Development of medical devices
  • Regulatory requirements EU MDR 2017/745 – part 1
  • Regulatory requirements EU MDR 2017/745 – part 2
  • Clinical investigations and risk management
  • Risk and clinical investigation stages
  • Clinical investigation milestones
  • Identifying stakeholders
  • Developing essential documents
  • Site selection – qualification of sites and investigators
  • EC and CA submissions and Agreements – part 1
  • EC and CA submissions and Agreements – part 2
  • Site initiation
  • Site management – Devices, documents, and training
  • Safety reporting
  • Site monitoring
  • End of enrolment
  • Site close-out
  • Clinical investigation report
  • Summary of sponsor responsibilities
  • Summary of investigator responsibilities
  • Preparing a clinical investigation budget
  • Setting up a successful clinical investigation – part 1
  • Setting up a successful clinical investigation – part 2
  • Course evaluation
NOTE – The course program structure is subject to change

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 cannot 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 10-15 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.
You will have access to the course for six months.
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.

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.

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

If you buy more than 5 seats, you may want to consider group a purchase, which will give you discounted prices for the 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.

The course is personal, which 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.

There is no certification or accreditation for clinical investigation training as such; however, the instructor is a member of the European MedTech community and is the founder and CEO of a medical device-focused CRO in Europe, with over 15 years of practical experience.

There are no pre-requisites for this course.

Testimonials

Group purchase

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, when buying for yourself, the course access is linked to the email address and the name you enter at 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, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.

Still haven’t decided?
Get in touch with us and get more information:

  • Hidden

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.