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