Article on Complaints and Reliability added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, there is an article that describes the role of reliability in complaints. QSR, ISO 13485:2003, and ISO 13485:2016 includes reliability in the definition, but none of defines or describes reliability. The article makes a recommendation on data analysis, uses a Warning Letter as an example, and explains how data analysis could have helped prevent the problem.