"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 FDAâs regulatory radar.
Highlights
- 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
Timings8:30 AM - 4:30 PM (Nov 07) (General)8:30 AM - 4:30 PM (Nov 08) (General) | Entry FeesPaid Ticket Starts from 1499 USD View Details |
Participants20 Delegates 5 Exhibitors Estimated Count | Category & TypeConferenceEducation & Training Food & Beverages |
Editions07 - 08 Nov 2019 1st EditionFrequency Bi-annual Next edition likely in May 2020 | Official LinksWebsite ContactsReport Error Claim this event |
Organizer![]() ComplianceOnline USATop Rated 356 events listed |
User Community [ Users who have shown interest for this Event ]

Lauren Clancy
Director Marketing at Syncro Medical
Langhorne, United States
Green Hills Software
Vice President Medical Industry Business Development at Green Hills Software
Franklin, United States
Rose Rios
Government at NJEDA
North Brunswick Township, United StatesWrite a Review
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Speakers

Casper (Cap) Uldriks
Former Associate Center DirectorVisitor Ticket Price
1499 USD | Attendee Seminar One Registration |
Venue Map & Directions

Four Points by Sheraton Philadelphia City Center
1201 Race St, Philadelphia, PA 19107
USA
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