INTRODUCTION TO CLINICAL INVESTIGATION FOR MEDICAL DEVICES AND ISO 14155
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - June 2024
Learn how to optimise the planning and conduct for clinical investigation of medical devices during this self-paced, interactive online course.
Select your pricing plan
ONLINE
YOU ARE HERE
€ 399
Average completion time 7-19 hours
Total video duration 4 hours
CPD points 13
Number of quizzes 31
Final exam
Digital course companion
Course certificate
Ask the instructor
6 months access to the course
ONLINE LIFETIME
€ 499
Average completion time 7-19 hours
Total video duration 4 hours
CPD points 13
Number of quizzes 31
Final exam
Digital course companion
Course certificate
Ask the instructor
Lifetime access to the course and instructor
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Course overview
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 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. There is also a downloadable course companion within 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).
- 'This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
Benefits for you
Become confident in setting up clinical investigations
After this course, you should understand the process of a clinical investigation and how to address good clinical practice (GCP) to assess the clinical performance, effectiveness, and safety of medical devices.
You should also be able to participate in 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.
Adaptive learning based on user input
We employ a unique approach to learning by utilizing the information gathered from thousands of quiz questions in our courses in order to continuously improve them. The statistics and feedback from your answers enable us to refine and perfect our courses, ensuring that all topics are thoroughly covered and comprehensible.
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.
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.
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).
Course modules
- 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
All in all, the average time to complete the course is 7-19 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).
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, 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.
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.
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 13 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.