Medical Devices

CDRH Industry Basics Workshop (All Day Webinar) – November 4, 2014

Webinar Materials

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.

Participants could choose to participate in any and/or all of the sessions. Each session began precisely at the scheduled time.

  • 10:00-11:00 am: Investigational Device Exemption (IDE) Program
  • 11:00-12:00 noon: 510(k) Program
  • 12:00-1:00 pm: de novo
  • 2:00-3:00 pm: Corrective and Preventive Actions (CAPA)
  • 3:00-4:00 pm: Electronic Medical Device Reporting (eMDR)

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


Page Last Updated: 11/08/2016
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