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Updated in [July 24th, 2023]
This course, "Introduction to Design Control for Medical Devices," provides an overview of the design control process for medical devices. It covers the definition of a medical device, the regulatory requirements for medical devices in the European Union and the United States, and the design control process for medical devices.
The course begins with an introduction to the instructor and a discussion of the definition of a medical device. It then covers the regulatory requirements for medical devices in the European Union and the United States. The course then moves on to discuss how the primary purpose of a medical device is achieved and how to meet the requirements of the market. Finally, the course provides additional resources for further study.
This course is designed for those who are new to the medical device industry and want to learn more about the design control process. It is also suitable for those who are already familiar with the design control process and want to refresh their knowledge. The course provides an overview of the design control process and is a great starting point for those who are interested in learning more about medical device design control.
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