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FDA Rule on Class II Medical Devices: Open Loop Fluid Therapy
$9.99
The course offers detailed insights into the FDA’s classification of the adjunctive open loop fluid therapy recommender as a class II medical device. Discover the special controls required for compliance, including clinical performance testing and software verification, ensuring the device’s safe and effective integration into healthcare practices. Enhance your understanding of the regulatory framework that governs innovative medical technologies.
In this course you will learn the following:
* Understand the classification process and criteria for the adjunctive open loop fluid therapy recommender.
* Identify the special controls required for compliance.
* Recognize the potential risks and mitigation measures associated with the device.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Additional information
| Federal Register Title | Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender. Document Number: 2024-19736 |
|---|---|
| Course SKU | FR-24-235-1 |
| Why This Course Is Important | Without this course, learners may miss out on understanding the critical compliance requirements and risk mitigation strategies necessary for the safe and effective use of the open loop fluid therapy recommender. |