Investigational Device Exemption

510(k) Clearances-FDA|Premarket Notifications 510(k)|510(k) Submission Process|Medical Device EntryПодробнее

SCiP by SpineX, a novel investigational treatment for Cerebral PalsyПодробнее

Understanding the FDA Pre-Market Approval (PMA) Process for Medical DevicesПодробнее

Johnson & Johnson to seek FDA approval for general surgery robot trial in late 2024 #JNJ #ISRGПодробнее

Presentation 13 - Development and Regulation of Medical Devices - Bill PritchardПодробнее

Lecture 5: Victor Krauthamer, Regulatory AffairsПодробнее

What Is An Investigational Device Exemption (IDE)?Подробнее

บทบาทหน้าที่ งานเครื่องมือแพทย์วิจัยทางคลินิก (Investigational device)Подробнее

US FDA Medical Device Registration Process Overview| US FDA Regulatory Pathway & ClassificationПодробнее

CRSO Training Series Device Basics Oct 5 2023Подробнее

Explaining Neuralink’s Human Trials ProcessПодробнее

Understanding the Investigational Device Exemption (IDE) ProcessПодробнее

SCiP, by SpineX a novel investigational device to treat Cerebral PalsyПодробнее

Investigational Device Exemption WorkshopПодробнее

FDA Product Regulations Part 6 of 7Подробнее

U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval ProcessПодробнее

Drugs & Devices in Research: An Introduction to Navigating FDA Oversight RequirementsПодробнее

What is a Class 1 and 2 device exemption?Подробнее

Neuralink: Beginner's Guide to Human Clinical TrialsПодробнее

Investigator Responsibilities - Safety Reporting for Investigational Drugs and DevicesПодробнее