Master Medical Device Development & Us Fda Regulatory Affair
Published 12/2025
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 14h 55m | Size: 14.2 GB
Learn Medical Device Regulatory Affairs, Classification, Intended Use, FDA Databases, Premarket Pathways & UDI Labels
What you'll learn
Master key parts of the U.S. medical device regulatory framework, from concept to - market.
Learn how to classify your device, write the intended use and indications for use statements and choose the right premarket pathway .
Gain practical how-to knowledge to enable you plan and execute performance and usability testing that meets FDA expectations as part of eSTAR submissions
Learn the key requirements for...