FDA's New Guidance On Medical Device Development Tools (MDDT); Qualification of MDDT for Patient Assessment

MessageThis Webinar is over
Date May 15, 2014
Time 10:00am
Cost $195.00
Online
Overview:
This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. An MDDT is a scientifically validated tool (test) to determine clinical outcome. Qualification reflects CDRH (FDA's) expectation that within a specified use the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making. 

Why should you Attend:
This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. Understanding this FDA process will enable the user of the MDDT to use such tools during the Medical Device development process. 

Areas Covered in the Session:
  • Description of an MDDT
  • Definitions for the MDDT qualification process
  • Overview of the qualification process
  • MDDT types
  • The CDRH qualification process
Who Will Benefit:
  • Regulatory Affairs Personnel
  • Clinical Personnel
  • Research Personnel
  • Quality Personnel
  • Legal Personnel
  • Personnel who require a general understanding of the FDA's MDDT process

 


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