Introduction

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

Deadlines

• Oct 08 2014
  Oral abstracts deadline

  

Useful links

• Further event details More information about the event

Speakers

• Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated, Canada

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Venue

Compliance Trainings

Compliance Trainings, Online, 5939 Candlebrook Ct, Mississauga, L5V 2V5, Canada

Useful links

• Venue information More information about the venue

Committee

• AAG Incorporated CEO, Canada

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Organised by

Compliance Trainings is the global organization for regulatory affairs professionals for those who have an interest in regulatory affairs in Food, drugs, Biologics, Medical, Healthcare, HR, IT sectors.

Compliance Trainings

Contact information

Uttam Mandal
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
4169154458
Contact us by email

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