2012 - Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar By GlobalCompliancePanel
Date2012-05-08
Deadline2012-05-08
VenueOnline Tra, USA - United States
Keywordsonline training,ISO 14971, Risk Management for Compliance,Proper Documentation,FMEA,Factors regulatory,risk management tools,standards compliance
Websitehttp://bit.ly/IByVa3
Topics/Call fo Papers
Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard.
However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971. This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and improved time to market with a lower risk product.
Areas Covered in the Session:
Exploring the Risk Management tool set
Choosing the right risk management tools
What tools are used during each phase of design?
Meeting Human Factors regulatory requirements
How to document standards compliance
How to develop an FMEA that meets requirements.
Who Will Benefit:
Product Risk Management
Design Engineers
Human Factors Engineers
Medical/Clinical Project Team members
Project Managers
Process Engineers
Quality Engineers
Tuesday, May 8, 2012
10:00 AM PDT | 01:00 PM EDT
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971. This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and improved time to market with a lower risk product.
Areas Covered in the Session:
Exploring the Risk Management tool set
Choosing the right risk management tools
What tools are used during each phase of design?
Meeting Human Factors regulatory requirements
How to document standards compliance
How to develop an FMEA that meets requirements.
Who Will Benefit:
Product Risk Management
Design Engineers
Human Factors Engineers
Medical/Clinical Project Team members
Project Managers
Process Engineers
Quality Engineers
Tuesday, May 8, 2012
10:00 AM PDT | 01:00 PM EDT
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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Last modified: 2012-04-17 13:06:17