MDR Module 8: Differences Between Medical Device Reports and Vigilance Reports

Most companies in our industry have complex global supply chains. In order to remain compliant with the expectations from Global Regulators, it is important to know the succinct differences between US and ROW expectations.

Differences between Medical Device Reports and Vigilance Reports includes insight on what global regulators send to each other regarding the safety of a medical device. Participants learn the expectations outlined by the Global Harmonization Task Force versus FDA regulation. A question and answer session takes place at the close of the main presentation.

 

Expert Faculty

Nancy Pressly
Health Scientist
Center for Devices and Radiological Health, FDA

(Expert faculty titles and companies may have changed since the time of recording.)
 

Level

Intermediate
 

Learning Impact

Upon completion of this training, participants will:

  • Gain comprehensive knowledge of FDA expectations and guidelines
  • Learn industry standard definitions/applications
  • Gain insights and answers to audience-generated questions
     

Price

$99 per module
$840 for entire series (Receive a 15% discount for purchasing all 10 modules)