Clinical Investigation for Medical Devices and ISO 14155

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399

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Welcome!

Welcome to the course Clinical Investigation for Medical Devices and ISO 14155

The goals for this course are that you should:

Understand the overall process of a clinical investigation of medical devices
Learn how to address good clinical practice (GCP)
Master how to participate in the design and planning of a clinical investigation, monitoring of clinical sites, and reporting of clinical data
Acquire skills in the use of various tools and techniques to ensure a successful launch, conduct, and close-out of the study

Practical information

1) Which internet browser to use

We support Chrome, Edge and Firefox.

Please ensure that your browser is updated to the latest version to avoid technical issues.

2) Mark lessons as complete to continue

We regularly update our online courses, and if any new topics are added, they must be marked as complete before you can continue the course.

If you have trouble progressing through the course, check if all your previous topics are marked as complete in the course navigation menu on the right-hand side. Completed topics have a green checkmark.

3) This course is personal

The name and email seen under ”My account” will be displayed on the course certificate. This course is personal and bound to the owner of the account. If you are using someone else’s account, please contact support and we will help you.

4) Trouble?

Don’t hesitate to reach out to us on support@medicaldevicehq.com.

Get your thinking cap on now and get started with the lessons below!

5) Change log

You can find any updates that we make to the course listed here. Please note, corrections of typos and minor changes are not included.

Date	Topic	Change
2025-08-26	General	All questions updated and feedback added
2025-09-11	Developing essential documents – Part 2	Updated EC REP symbol to EU REP symbol
2025-09-16	General	“Introduction to” has been removed from the online course title

Course Content

Lesson Content

0% Complete 0/5 Steps

Download your course companion – Part 1 (CLI1O)

Welcome (4 min) (CLI1O)

What you need to know (7 min) (CLI1O)

Set your course goal completion date (CLI1O)

Pre-course assessment (CLI1O)

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Introduction to clinical research of medical devices (7 min)

What is a medical device? (7 min)

Clinical research of drugs vs devices (6 min)

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What is good clinical practice (GCP)? (6 min)

Who must follow GCP? (8 min)

ISO 14155 content, clauses, and annexes (7 min)

Major changes in the new version ISO 14155:2020 (6 min)

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Development of medical devices (7 min)

Regulatory requirements EU MDR 2017/745 – Part 1 (7 min)

Regulatory requirements EU MDR 2017/745 – Part 2 (8 min)

Clinical investigations and risk management (13 min)

Risk and clinical investigation stages (5 min)

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Clinical investigation milestones (4 min)

Identifying stakeholders (7 min)

Developing essential documents – Part 1 (8 min)

Developing essential documents – Part 2 (8 min)

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Download your course companion – Part 2 (CLI1O)

Site selection – qualification of sites and investigators (10 min)

EC and CA submissions and agreements – Part 1 (8 min)

EC and CA submissions and agreements – Part 2 (9 min)

Site initiation (7 min)

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Site Management – Devices, documents, and training (13 min)

Safety reporting (11 min)

Site monitoring (11 min)

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End of enrolment (4 min)

Site close-out (4 min)

Clinical investigation report (4 min)

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Summary of sponsor responsibilities (3 min)

Summary of investigator responsibilities (6 min)

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Preparing a clinical investigation budget (6 min)

Setting up a successful clinical investigation – Part 1 (6 min)

Setting up a successful clinical investigation – Part 2 (10 min)

Lesson Content

Lesson Content

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