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.
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Course length
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approx.
10-15 hours |
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Course fee
(per person)
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€ 399
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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 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
Become confident in setting up clinical investigations
Become confident in setting up clinical investigationsThe 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.
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!
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
- Final exam
- Course evaluation
Frequently asked questions
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, 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.
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.