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FDAnews Announces — Medical Device Risk Management: From Understanding to Applications, Nov. 5-6, 2014
Date:8/25/2014

Falls Church, VA (PRWEB) August 25, 2014

Medical Device Risk Management:
From Understanding to Applications
**Presented by Ombu Enterprises and FDAnews**

http:// http://www.fdanews.com/MDRiskMgmntChicago
All device professionals know they have to perform risk management.

And to do it, many firms rely on the widely accepted standard for product risk management: Failure Modes and Effects Analysis (FMEA).

But with the FDA and international regulatory bodies ramping up risk management requirements, and the potential for serious injury (even death) present in many medical devices, is FMEA enough? Experts say no.

FDA QSR guru Kim Trautman lays it out very clearly:
"I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA. That is NOT a risk management system."

If that statement leaves devicemakerss grasping to find new methods to assure they’re performing the best possible risk assessment, there are options.

Here are five additional methods drawn from the chemical, aerospace, nuclear and food safety industries:

o     Event tree analysis (ETA)
o     Fault tree analysis (FTA)
o     Hazard analysis and critical control points (HACCP)
o     Preliminary hazard analysis (PHA)
o     Hazard and operability studies (HAZOP)

Where can devicemakers learn more about
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