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Track 3 Session 2
10:30 to 11:30 a.m. Tuesday June 17, 2008
Application of Risk Management to Medical
Devices: Effective Reliability Integration
The FDA and the international
community have recognized and adopted ISO14971, Application of Risk
Management to Medical Devices, as the framework to manage the risks
associated with the use of medical devices. Within this framework,
reliability plays a critical role to assess, control and help manage
hazardous situations that may pose risks to patients, users and
equipment.
This presentation provides an overview of ISO14971 itself as well as
the regulatory background necessary to understand the importance of
ISO14971 as the framework for managing risks associated with medical
devices. Major risk management program elements will be explained
with specific emphasis on how, when and why to apply reliability
best practice techniques and to ensure they are effectively
implemented and maintained. Specific reliability tools and techniques
include FTA, DFMEA, PFMEA, Usability Analysis, Risk Probability
Estimation and Data Collection and Analysis Systems.
Key Words: ISO14971, Risk
Management, FMEA, FTA, Usage Parameters, Intended Use, Hazardous
Situations, Probability of Hazardous Situations, Probability of
Harm, Severity of Harm, Risk Analysis, Risk Estimation, Risk
Evaluation, Risk Control, Residual Risk Acceptability
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