Sahni, A.; Kim, J. (1990, ASQC) Medtronic, Inc., Minneapolis, MN
Failure Mode, Effects, and Criticality Analysis is one of the most crucial activities required during the development of a biomedical device. The more critical the device is, the more rigorous and thorough FMECA should be conducted. With this analysis, the design and reliability engineers can focus on preventive and corrective steps to be taken to achieve the required reliability goals. FMECA starts with the early design and is updated with changes in the design of components and products as the development process progresses. This paper describes a detailed Failure Mode, Effects, and Criticality Analysis of a biomedical device, i.e., an implantable pacing lead.