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Event Contacts


Event Manager
NetZealous - Compliance4All
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Event Overview: 

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: support@compliance4All.com
http://www.compliance4all.com/
Event Link :  http://bit.ly/1MCN2jf

If the Webinar on FDA Regulation of Medical Device Software is important to your business, act now and make the appropriate connections. See the contact information below.

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Event Details

Website: http://bit.ly/1MCN2jf...
Conference/Event Dates: 11/30/2015 - 11/30/2015
Classification: B2B
Primary Industry: Food / Beverage
Other Industries: Business, Clinical Pharmacology, Food / Beverage, Professional Healthcare, Software, Technology
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: Compliance Manager
Validation Manager
Regulatory Manager
QC Managers
QA Managers

Booth Details

Booth Size Booth Cost   Available Amenities
No exhibiting.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

Advance Networking

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Webinar on FDA Regulation of Medical Device Software

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