Dr. Harvey Rudolph

Harvey Rudolph

HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that standard and is working on the new ISO risk management guidance document.

His 37 years experience with medical devices include 25 years at FDA, where he held a variety of positions and retired as deputy director of the medical device laboratory. He also worked for seven years at Underwriters Laboratory, where he was the global program manager for medical devices developing programs to help clients deal with the global medical device environment.

He brings a wealth of knowledge and practical experience to this risk management workshop, having trained and consulted for numerous large and small companies throughout the world.

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