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Seminar on Overview of Device Regulation - FDA  

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By:

Global Compliance Panel   

For:

Regulatory professionals working in the medical device field

Cost:   

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Seminar Summary:

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices (see full course description)

 

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Training Course Syllabus:


Overview of Device Regulation - FDA

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.

Why should you attend:

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.

Areas Covered in the Session:

Describe the elements impacting the definition and classification of medical devices
Determine the points to consider in the development of a regulatory strategy
Define the tools for regulatory strategy development
Recognize sources of regulatory and competitive intelligence
Identify the elements of a regulatory plan
Apply regulatory principles to develop a regulatory plan

Seminar Summary:

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices (see full course description)

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