Track 2 Session 4
2:20 to 3:20 p.m. Tuesday June 9, 2009

Reliability Plan for Medical Devices

Reliability is an important performance characteristic for all medical devices, but it is especially critical for those medical devices classified as either life sustaining or life supporting in nature. In these cases, it is important for the reliability engineer to take a life-cycle view and ensure their effective involvement at each project phase. This presentation provides a basic overview of the applicable FDA regulations concerning the required quality system elements that must exist in order to design, develop, manufacture, distribute and market for sale a medical device. Key quality system elements include design control, risk management and CAPA elements. The presentation will provide detailed treatment of how to identify effective reliability activities/tasks and then create a life-cycle reliability plan for medical devices. Real-world examples and counter-examples will be included and discussed. The presentation will also identify how, when and where to integrate the reliability plan, activities and tasks into other FDA required programs such as design control, risk management and CAPA programs. Specific reliability tools and techniques will include customer expectations, system reliability goals, usability analysis, critical item identification and control, FTA, design and process FMECA, risk probability estimation, reliability testing strategy, HALT, burn-in, HASS, and FRACAS or alternative data collection and analysis systems.

Key Words: ISO14971, Risk Management, Use Profile, Use Environment, Life Data, Goals and Requirements, Design Activities, Analytical Methods, Assessment Methods, Testing Strategy, Production Activities, Post Production Monitoring, FMEA, FTA, Usage parameters, Corrective Action/Preventive Action (CAPA), Complaints, Non-Conformances, Quality System Regulation (QSR), 21CFR820