Assessment of Reliability Standards and Test Methods for Implantable Medical Electronic Devices – (PPT)

摘要

Goal: Standardization of qualification test methods most applicable to implantable medical devices and identification of areas most in need of standards development will offer to the industry as well as to the patient a faster level of innovation, a higher profit, and lower personal and litigation risks. Our approach to achieving this goal is separated into two phases: Phase 1: Review of Reliability Standards Relevant to Implantable Medical Electronic Devices. Phase 2: Gap Analysis and Recommendations.