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

Falls Church, VA (PRWEB) August 25, 2014

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

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 these methods? At FDAnews' workshop, Medical Device Risk Management: From Understanding to Applications.

Although these methods are less widely known and used within medical device companies, they can provide attendees with confidence that their products have passed rigorous risk assessment and management review. They can also demonstrate a commitment to compliance and patient safety to regulatory authorities.

This is just one example of the kind of invaluable insights attendees will find at this always in demand FDAnews conference being led by Dan O'Leary, one of the industry’s chief risk management gurus and an esteemed instructor.

Here's more of what Dan will have in store for attendees Medical Device Risk Management: From Understanding to Applications. In two action-packed days, he will:

  •     Help to establish, maintain and audit a highly effective risk management program implementing ISO 14971:2007
  •     Show how to integrate risk management with the FDA’s QSR and ISO 13485 quality management systems
  •     Demonstrate the differences between hazards, harms and risks, and the unique tools to evaluate each one
  •     Teach attendees to develop a risk evaluation matrix, assessing the probability of occurrence and the severity of harm
  •     Tell attendees how to better use many types of risk management tools, such as FMEA, FTA and HAACP
  •     And much, much more.

Let's face it: today it's no longer good enough to understand the basics of risk management. Devicemakers must be knowledgeable about how to build, maintain and audit risk management programs.

Plan to attend this two-day workshop and be ready to set up a new comprehensive risk plan, or pick an existing one apart to make it better.

Who Will Benefit:

  •     Project managers involved in design and development
  •     Design engineers
  •     Quality engineers
  •     Manufacturing engineers
  •     Quality auditors
  •     Production managers
  •     Scientists involved in device research and development
  •     Medical staff evaluating risk, safety or effectiveness
  •     Quality or regulatory staff assigned to complaint, CAPA or MDR management
  •     Training personnel
  •     General/corporate counsel

Meet the Instructor:
Dan O’Leary has more than 30 years’ experience in quality, operations and program management in regulated industries including, aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Conference Details:
Medical Device Risk Management:
From Understanding to Applications
**Presented by Ombu Enterprises and FDAnews**
Nov. 5-6, 2014 — Schaumburg, IL (Chicago)

Tuition: $1,797

Easy Ways to Register:
Online:    http://
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at

Source: PRWeb
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