Date :
Place : United States, San diego
Contact Person:Paula Edwards
Description:
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.Deadline for abstracts/proposals : 15th November 2017
Organized By :New York Events List
Keynote Speakers : Former Associate Center Director of FDA's CDRH Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health.
Conference Highlights :Understanding FDA legal authority Applying FDA classifications / risk controls Understanding FDA and NIST software guidance Identifying the quality system regulation for risk management, software verification and validation Identifying cybersecurity issues and developing a planned response Identifying and resolving interoperability issues
Venue :San Diego, CA, United States
Check the event website for more details.