Falls Church, VA (PRWEB) April 29, 2015

Medical Device Risk Management:

From Understanding to Applications

**Presented by FDAnews and Ombu Enterprises**

July 14-15, 2015 – Boston, MA

http://www.fdanews.com/MDRiskManagement

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 manufacturers startled and wondering about their risk management strategies, there is a solution.

Make plans today to attend, Medical Device Risk Management: From Understanding to Applications. Limited seating exists for this always in demand FDAnews workshop led by Dan O’Leary, one of the industry’s chief risk management gurus and an esteemed instructor.

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


    help transition from the now obsolete IEC 62366:2007 to the updated IEC 62366-1:2015 — don’t get caught during the next inspection applying an out-of-date standard!

    discuss the limitations on risk management activities from the EU product directives (MDD, IVDD, and AIMD) documented in EN ISO 14971:2012

    help attendees 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 (easier said than done, and most firms can’t really show regulators sufficient documentation)

    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 how to better use many types of risk management tools, such as FMEA, FTA and HAACP

    and much more.

And, as always, Dan will employ case studies throughout the two days to demonstrate effective risk management. Attendees will get out of their seats and actively participate with their colleagues in 4 challenging hands-on exercises.

Today it’s no longer good enough to understand the basics of risk management. Manufacturers must be knowledgeable about how to build, maintain and audit risk management programs.

So, plan now 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.

Putting these programs in place assures that manufacturers will develop safe and effective products … achieve competitive standing in the marketplace … and do it all with the confidence that they are fully complying with FDA and other international regulations.

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 FDAnews and Ombu Enterprises**

July 14-15, 2015 – Boston, MA

http://www.fdanews.com/MDRiskManagement

Tuition: $ 1,797

Significant team discounts are available.

Easy Ways to Register

Online: http://www.fdanews.com/MDRiskManagement

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.






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