510(k) Submission Process

FDA Medical Device Regulation for Everyone
Duration:  Unlimited
Cost:  49  USD
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This 510(k) Submission Video Course is designed to help you discover the 510(k) submission process and provide you with an overview on the submission review process, and applicable timelines.
Length: 00:30

FDA Medical Device Development Tools (MDDT) Program

FDA Medical Device Regulation for Everyone
Duration:  Unlimited
Cost:  49  USD
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This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the Medical Device Development Tools Program, this program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
Length: 00:20
Duration:  Unlimited
Cost:  49  USD
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This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the monitoring essential guidelines for medical devices in the US. She brings to you her professional perspective which stems from her extensive background as an FDA inspector.
Length: 00:10
Duration:  Unlimited
Cost:  49  USD
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This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the fundamental concepts of global quality for medical devices and clinical trials. She brings to you her professional perspective which stems from her extensive background as an FDA inspector.

Length: 00:20