This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout.
ISO 14155 2020 Clinical Trial from Start to Finish
$99.00
- Course Type: Video Lessons
- Language: English
- Level: Advanced
- Session: year 2020
- Time: 0 - 1 Hour
Original price was: $495.00.$470.25Current price is: $470.25.
Course Breakdown
| Section | Time |
|---|---|
| Introduction | 00:01:09 |
| Regulatory Information | 00:08:07 |
| Submission Preparation | 00:05:29 |
| Acceptance Review | 00:06:57 |
| AI Request and MDUFA | 00:06:08 |
| Conclusion | 00:08:12 |
Exam and Certifications
- Final Test – ISO 14155 2020 Clinical Trials from Start to Finish
- Certification
Description
What I will learn?
This tutorial provides an overview of the main changes introduced by ISO 14155: 2020 on different steps of the clinical investigation:
- Understand what is a 510(k) submission
- Explore the types of 510(k) submissions
- Discover the preparation of the submission and submission review procedure
- Learn who should submit a 510(k)
- Understand when a 510(k) it would not be required
Skills I will gain
You will be able to clearly understand the new requirements and identify those already provided by ISO 14155:2011 and confirmed by the new version of the standard.
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