Roundtable - Update on Software Regulations: FDA’s 21st Century Cures AcT, and the EU’s Medical Device Regulation (MDR)-2017-06-28

Event Information
Event Name: 
Roundtable - Update on Software Regulations: FDA’s 21st Century Cures AcT, and the EU’s Medical Device Regulation (MDR)
Event Date: 
06/28/2017 - 7:00pm
Event Location: 
Stellartech Research Corporation 560 Cottonwood Drive Milpitas, CA 95035
Event Details
Event Type: 
Lecture
Event Details: 

JUne 28th Roundtable - Update on Software Regulations: FDA’s 21st Century Cures AcT, and the EU’s Medical Device Regulation (MDR)

George J. Marcel
Director of Quality Assurance at TheraNova LLC

Update on Software Regulations: FDA’s 21st Century Cures AcT, and the EU’s Medical Device Regulation (MDR)
Wednesday, June 28, 2017, 7:00 to 9:00 pm
Register for online discounts - ahead of the roundtable event.
Topic: “The 21st Century Cures Act,” 2016, codifies the FDA’s positions on when software is a medical device, and when it isn’t, that have been published in guidance documents. This presentation will review Section 3060, “Clarifying Medical Software Regulation.” In addition, Tim will review the more extensive requirements for software in the MRD. The playing field and rules are changing in the domestic and international arenas! Learn about the changes in time to meet the new requirements as part of your development process, and not after development is complete. This is the best chance this year to learn what those new rules are.

Featured Speaker: Tim Stein

Tim founded Business Performance Associates, Inc., a consulting firm located in Cupertino, California in 1994.

Moderator: Barry Craner, former Vice President of Quality and Regulatory, Stellartech Research Corporation, FASQ.
Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035

For full details & to register - go to Eventbrite: ncdgjun2017.eventbrite.com

https://www.eventbrite.com/e/33182125631?aff=efbneb