Webinar on FDA Regulation of Medical Device Software
from Compliance4allOverview:
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. FDA did not have to create a software regulatory policy until the late 1980's when companies began incorporating primitive software programs in medical devices. Software can be a device by itself (i.e., stand-alone) or it can be incorporated into another device as a component, part or accessory. Under the current policy, FDA distinguishes between stand-alone software and software that is a component, part or accessory to a device.
Why should you Attend:
To gain a fundamental understanding of FDA regulation of medical device software.
Areas Covered in the Session:
Definition of medical device software
FDA's medical device software regulatory scheme
Software validation
Level of concern
Who Will Benefit:
Compliance Manager
Validation Manager
Regulatory Manager
QC Managers
QA Managers
Speaker Profile:
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://bit.ly/1MCN2jf (from )
-
This event has passed.
November 30, 2015 from 10:00 to 11:00 amNovember 30, 2015 10:00 to November 30, 2015 11:00 -
Online Event
, Fremont, CA -
Contact Event Manager for more information
18004479407 or [email protected]
Directions are calculated based on the address provided by the event submitter and may not be precise. Please contact the event coordinator for more detailed information.
