Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.
An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com
