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2020 - A Comprehensive View of FDA Regulations for Medical Devices
Date2020-07-16 - 2020-07-17
Deadline2020-07-06
VenueTampa, FL, USA - United States 
KeywordsFDA QSR; Medical device reports; Quality management system
Topics/Call fo Papers
This two day interactive course on FDA regulations for medical devices will:
Cover more than just the Quality Management System
Provide an overview of regulations and how they fit together
Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
Teach the current device marketing regulations
Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s
Cover more than just the Quality Management System
Provide an overview of regulations and how they fit together
Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
Teach the current device marketing regulations
Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s
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Last modified: 2020-04-03 02:38:32