Speaker: Frances Cohen
Presentation topic: Cybersecurity and the FDA
Synopsis: As thousands of medical devices have proven vulnerable to attacks, the FDA is making sure device manufacturers proactively manage cybersecurity risks. This talk discusses the premarket and upcoming postmarket cybersecurity guidance from the FDA for medical devices.
About the Speaker:
As President of Promenade Software, Frances emphasis is to provide clients with advanced technologies, robust quality, and outstanding service for their medical device software. They provide the full stack of capabilities from embedded to cloud, with advanced test software built in. Frances is passionate about quality, starting with a solid, proven software design and pre-validated framework. With more than 15 years experience leading software teams in medical devices, she has overseen development and release to market of dozens of products, including in vitro diagnostic instruments, tissue ablation, laser therapy, heart defibrillators and several other class II and III instruments. Frances is an expert in FDA software regulatory requirements, IEC 62304, and TIR 45, and can make sure your software submission follows all guidelines for acceptance.
The Lunch & Learn event is an opportunity for Experts-in-Residence (EiRs) to present informal talks and Q&As with startup teams working at the Cove. The talks will cover such diverse topics as branding, marketing, pitching mistakes to avoid, investor relations, and prototyping.
Check-in 11:30 am Open to UCI students, staff & faculty, alumni, startups, spinoffs & Cove EiRs.