MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Product Risk Management - ISO 14971:2007

Event Details

Product Risk Management - ISO 14971:2007

Time: September 30, 2015 from 10am to 11am
Location: Online Event
Street: Online Event
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 8004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Aug 5, 2015

Export to Outlook or iCal (.ics)

Event Description

Overview: 

This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.

The U.S. FDA has stated that the use of a medical device entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 provides an accepted vehicle by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing. 

Areas Covered in the Session:

  • The Revised ISO 14971:2007
  • Product Hazard Analysis
  • Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
  • Fault Tree Analysis
  • The Team and It's Involvement – Who, When and How
  • Product Risk Management File and Report
  • Using the Completed Document – It’s Real Value
  • Keeping it "In the Loop"
  • A "Living Document" 

Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
support@compliance4all.com
www.compliance4all.com
Event Link :http://www.compliance4all.com/control/w_product/~product_id=500445LIVE/

Comment Wall

Comment

RSVP for Product Risk Management - ISO 14971:2007 to add comments!

Join MedTech I.Q.

© 2024   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service