2014 - Webinar On FDA’s New Guidance On Medical Device Development Tools (MDDT)

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.
Learn about MDDTs
Learn about criteria for the MDDT qualification program
Learn about the definitions associated with the MDDT qualification program
Learn the MDDT qualification process
Learn about the MDDT submission process
Areas Covered in the Session :
Description of an MDDT
Definitions for the MDDT Qualification Process
Overview of the Qualification Policy
MDDT Types
The CDRH Qualification Process
Interactive Q&A session
Who Will Benefit:
Regulatory Affairs Personnel
Quality Personnel
Manufacturing Personnel
Research Personnel
Clinical Personnel
Legal Personnel
Personnel who require a general understanding of the FDA’S MDDT Qualification Process
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299