1st Edition  Conference

FDA's Medical Device Software Regulation Strategy

"Understanding FDA legal authority"
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.This seminar will help those involved in overcoming these commercial and regulatory obstacles. It will highlight the need for firms to remain current with technological tools and strategy to remain competitive, and ideally, outside FDA’s regulatory radar.


  • Office of the National Coordinator (ONC) for Health Information Protection,Types of Software Devices
  • National Institute of Science and Technology Report,Device Vulnerabilities: Malfunction and Failure
  • National Institute of Science and Technology Report and Collaboration,FDA Regulatory Strategy
  • Criteria for corrective and preventive action deemed recalls,FDA Regulation of Accessories
  • Federal Communications Commission (FCC) Regulation,Labeling: Instructions for Use and Precautions


8:30 AM - 4:30 PM (Nov 07) (General)
8:30 AM - 4:30 PM (Nov 08) (General)

Entry Fees

Paid Ticket Starts from 1499 USD View Details



5 Exhibitors Estimated Count

Category & Type

Education & Training
Food & Beverages


07 - 08 Nov 2019 1st Edition

Frequency Bi-annual
Next edition likely in May 2020

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Lauren Clancy

Lauren Clancy

Director Marketing at Syncro Medical

Langhorne, United States
Green Hills Software

Green Hills Software

Vice President Medical Industry Business Development at Green Hills Software

Franklin, United States
Rose Rios

Rose Rios

Government at NJEDA

North Brunswick Township, United States

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Casper (Cap) Uldriks

Casper (Cap) Uldriks

Former Associate Center Director

Visitor Ticket Price

1499 USDAttendee Seminar One Registration
39.956018 -75.159107

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Four Points by Sheraton Philadelphia City Center

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