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Course Content :
This one-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 requirements of ISO 14971
- 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
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F. David Rothkopf will teach this seminar. He has more than 15 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.
DATE: October 16, 2006
Location: Holiday Inn, Mansfield, MA
Time: 9:00 am to 5:00 pm
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