World Conference Calendar

32801 Conferences

Webinar on Medical Device Tracking

Added by Referral on 2010-12-10

Conference Dates:

Start Date Start Date: 2011-02-10

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

Understanding of latest FDA guidance requirements and expectations related to medical device tracking and what are the new changes.

Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II or class III devices: (A) the failure of which would be reasonably likely to have serious adverse health consequences; or (B) which is intended to be implanted in the human body for more than one year; or (C) which is a life sustaining or life supporting device used outside a device user facility.

This medical device tracking webinar training will address the latest FDA guidance requirements and expectations and expound on why and what are the information, the tracking methods must provide about the location of a tracked device. We will also discuss the role and responsibilities and the impact with user facilities and patient issues.
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