Complying with the FDA’s Rule on LDTs – What you need to Do and When

Описание к видео Complying with the FDA’s Rule on LDTs – What you need to Do and When

This webinar will build off our June 3rd webinar , focusing on the specific regulatory change’s labs need to start working on and the decisions they must make, while offering practical guidance on how to meet the new regulatory requirements. The program will spotlight stages 1 & 2 of the regulation, such as issues pertaining to medical device reporting, registration, and labeling requirements, among others, while also addressing elements of stage 3 involving quality system requirements and design controls.

Join our experts to learn how to comply with this important regulation

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