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

Event Details

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

Time: October 9, 2014 from 1pm to 3pm
Location: Online event, Canada
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Oct 7, 2014

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Event Description

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

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1401

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