Introduction to Clinical Investigation for Medical Devices and ISO 14155ONLINE COURSE
Learn how to optimise the planning and conduct of clinical investigations for medical devices during this self-paced, interactive online course.
|Course length||10-15 hours|
Purchase the course access for single user:
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 provision.
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 premarket and post-market setting.
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 will receive a course certificate upon successful completion of the course
Maria Nyåkern, Ph.D., is a consultant, entrepreneur, and B2B service provider in the medical device industry; she is the founder of AKRN Scientific Consulting, a CRO specializing in medical devices and minimally invasive cardiovascular therapies. She is also part of SIS / TK 340 and ISO / TC 194 Biological and clinical evaluation of medical devices.
Maria has substantial hands on experience, having set up and managed dozens of clinical investigations, and tens of thousands of patients, for different medical devices and indications for many of the top ten medical device manufacturers in the industry.
Maria is also a highly valued and respected trainer on clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard.
Benefits for you
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.
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, clinical strategy meeting, or job interview. Show that you know your stuff and present this course certificate!
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.
0 Base Course
Lesson 1. Introduction
- What you need to know
- Set your course completion date
- Pre-course assessment quiz
Lesson 2. Clinical research of medical devices
- Introduction to clinical research of medical devices
- What is a medical device?
- Clinical research of drugs vs devices
Lesson 3. Good clinical practice and ISO 14155
- 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
Lesson 4: How to study and market a medical device
- 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
Lesson 5. Clinical study planning
- Clinical investigation milestones
- Identifying stakeholders
- Developing essential documents
Lesson 6. Clinical study start up
- 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
0 Base Course
Lesson 7. Clinical study conduct
- Site management – Devices, documents, and training
- Safety reporting
- Site monitoring
Lesson 8. Clinical study termination
- End of enrolment
- Site close-out
- Clinical investigation report
Lesson 9. Summary of responsibilities for clinical investigations
- Summary of sponsor responsibilities
- Summary of investigator responsibilities
Lesson 10. Financing and managing a clinical investigation
- Preparing a clinical investigation budget
- Setting up a successful clinical investigation – part 1
- Setting up a successful clinical investigation – part 2
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?
How long does it take to complete the course?
How long will I have access to the course?
What if I lose internet connection during the final exam?
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?
What payment methods will you accept?
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.
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?
There is no certification or accreditation for clinical investigations 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.
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, when buying for yourself, 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, 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?
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