Webinar for Special 510(k) Submissions Published 2018-05-27 Download video MP4 360p Download video MP4 720p Recommendations 04:07 513g Request Webinar Overview 1:06:28 Mastering your 510(k) submission process 1:33:59 510(k) Project Management - Updated for 2021 1:36:15 Software Validation Documentation for FDA 510(k) pre-market notification submission 3:11:18 Robert Greene: A Process for Finding & Achieving Your Unique Purpose 36:02 Medtech Experience: You say 510k but FDA says DeNovo with Spencer Jones 12:06 What is a Class 1 and 2 device exemption? 1:57:56 Pavel Tsatsouline on the Science of Strength and the Art of Physical Performance | Tim Ferriss Show 38:26 How to prepare an FDA eSTAR 510(k) submission 3:53:53 Machine Learning for Everybody – Full Course 53:25 My Mystery Symptoms and Mast Cells 59:10 Design Controls 101 and Implementation Best Practices - Galen Data 15:51 When do you add a supplier to your ASL and why? 1:34:30 How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage 3:28:33 Scrum Master Full Course | Scrum Master Certifications Training | Scrum Master Tutorial |Simplilearn 08:51 Human Factors and Usability Testing for a 510(k) Submission 16:18 How is My Medical Device Classified? 2:00:06 Dr Joe Dispenza: You MUST Do This Before 10am To Fix It! 05:35 Importing Food Products to the US Part 1: Prior to Shipping to a USA Port / Tim Forrest 37:47 Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance Similar videos 06:34 510(k) Submission Predicate Selection Webinar - Updated for 2022 1:22:14 Webinar: Medical Devices Cybersecurity in 510(k) Premarket Submissions 1:24:09 510(k) Pre-Submission Webinar - Stop Wasting Time and Request a Pre-Sub Meeting 1:19:59 The 510(k) Submission: Requirements, Contents, and Options 1:08:44 Cybersecurity Webinar - Learn what the FDA wants in your 510(k) 1:34:30 How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage | Updated 03:05 Utilization of Special 510k Submissions Pathway Benefits Scenario Analysis Demo 02:17 Basics of 510(k) Clearance Process 1:15:12 510(k) Clinical Data Webinar presented with Factory CRO 1:07:58 How to Prepare a 510(k) Quality Submission 52:43 Webinar: Sterility Information in Premarket Notification (510k) Submissions for Medical Device 1:19:59 Requirements Contents and Options : The 510k Submission 22:49 FDA eCopy Webinar 1:16:16 510(k) Project Management Best Practices 58:17 Mastering FDA eSTAR Cybersecurity Requirements for 510(k) Submissions More results