Webinar: Introduction to US FDA Medical Device Regulations (510k, De Novo, IDE, CAPA, eMDR)
Channel: Invent Healthcare
Date: 21/08/2017

November 2014 Industry Basics Workshop IDE 510k de novo CAPA eMDR

Webinar: CDRH Industry Basics Workshop
Summary: This workshop (presented by webinar) provided information on the fundamental concepts of medical device regulations.

The workshop featured five sessions, each of which consisted of a presentation followed by a question and answer (Q&A) session with a panel of experts. Participants were able to email or call us with questions during each session.

Slides: 
Investigational Device Exemption (IDE) Program: http://bit.ly/IDEBasics
510(k) Program: http://bit.ly/510kBasic
de novo: http://bit.ly/DenovoBasics
Corrective and Preventive Actions (CAPA): http://bit.ly/CAPABasics
Electronic Medical Device Reporting (eMDR): http://bit.ly/eMDRBasics

Target Audience: Medical Device Industry, Medical Device Developers, Medical Device Industry Associations