FDAnews Announces: Medical Device Risk Management Workshop, Nov. 6-7, Chicago, IL

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Is Failure Modes and Effects Analysis (FMEA) the cornerstone of a company's medical device risk management program? Imagine, in two days attendees can learn about 5 new risk management tools and 4 emerging new standards to transform their company's risk management program.

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Medical Device Risk Management

“Are FMEA or FMECA… good tools? Yes. They are very good tools that can be utilized. Are they in and of themselves a risk management system? Absolutely not."—— Kimberly Trautman, Associate Director, International Affairs, QSR Expert, CDRH, FDA

Medical Device Risk Management
Beyond FMEA —New Tools to Assure Your Risk Management Program Meets New Standards
**Presented by Ombu Enterprises and FDAnews**
Nov. 5-6, 2013 — Chicago, IL

FDAnews and Dan O’Leary, President of Ombu Enterprises, have developed a comprehensive workshop that is packed with immediate use tools and techniques to improve current programs. This course goes well beyond FMEA to show attendees how its limitations could be their downfall.

Plus, the program provides interactive sessions to put the tools to use in mock scenarios.

Learn how ETA, FTA, HACCP, PHA and HAZOP could be the keys to avoiding a device disaster.

And as a bonus; this tightly focused workshop, will explain 4 new standards that call out ISO 14971 and how they can be integrated into a risk management program. The new standards include:

  •     IEC 60601-1, Medical electrical equipment — Part 1: General requirements         for basic safety and essential performance
  •     IEC 62304, Medical device software — Software life-cycle processes
  •     FDA Draft Guidance — Applying Human Factors and Usability Engineering             to Optimize Medical Device Design
  •     The basic concepts of the assurance case

Seating is at a premium for this event — Register today. Other areas the event will focus on include:

  •     How the FDA and international regulatory bodies measure the severity of a risk and what the different levels of seriousness are
  •     How to create and administer a risk management file — think of it as your risk management file cabinet
  •     Understand how to score risks and create a risk “scorecard” — how to use severity and probability
  •     Tips to assure that all your risk management reports contain the 9 checklist items all reports should have
  •     And much more

Attendees will leave this workshop a much better risk management professional.

Register today


  •     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

Dan O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. He is president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. O’Leary has a master’s 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.

Medical Device Risk Management
Beyond FMEA —New Tools to Assure Your Risk Management Program Meets New Standards
**Presented by Ombu Enterprises and FDAnews**
Nov. 5-6, 2013 — Chicago, IL

TUITION: $1,797 per attendee

Online:     http://www.fdanews.com/MDRiskMgmnt
By phone: 888-838-5578 or 703-538-7600

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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Michelle Butler
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