UNDERSTANDING AND IMPLEMENTING FOR RISK MANAGEMENT - MEDICAL DEVICES

This two-day risk management course is designed to provide participants with the knowledge, tools, and confidence to effectively develop a risk management program. As a management tool used throughout a product's life, risk analysis can reduce errors, liability and cost by prioritizing the most important risk concerns early. The course will feature both lecture and an active question-and-answer portion to bring real life situations to participants. Please bring risk issues to discuss.

Risk management is required by ISO 13485:2003, FDA QS regulations, and Annex I Essential Safety Requirements of the EU's MDD. This course will give engineers, operational and quality personnel, and management practical knowledge to not only discover but also organize, document, and mitigate risks. Participants will learn different techniques to identify risks such as Design and Process Failure Modes and Effect Analysis, Fault Tree Analysis, and Root-Cause Analysis.

The course will show participants how risk management can be used not only in the design of the product but also during corrective actions, complaints, service and next generation development. Risk management should be an integral part of any lesson-learned portfolio.

What you will learn

• Understand the principles of risk management planning in developing procedures and practices to analyze, evaluate and mitigate risks
• Understand what the FDA and EU will expect from your company in applying risk analysis to medical devices
• Understand the application of risk analysis methodologies such as FMEA and FTA to medical devices

F. David Rothkopf will teach this seminar. He has more than 13 years of professional strategic experience in the development and regulatory control of medical devices. In addition to being a Vice President at MEDIcept Inc., David has been instrumental in starting three medical device companies. David's expertise includes technical and hands-on knowledge in a variety of management, quality and regulatory processes. He has trained many large and small medical companies on the intricacies of risk management and hazard mitigation throughout a product life cycle. Mr. Rothkopf holds both a Bachelor and Master of Mechanical Engineering degree from WPI and an MBA from Boston University

WHEN: October 18, 2004
WHERE: Best Western Royal Plaza Marlborough, MA
TIME: 9:00am to 5:00pm