FDA 483 - Conformis, Inc. - September 20, 2019

ConforMIS, Inc., a medical device manufacturer in Billerica, MA, was inspected regarding its quality system for the iTotal Hip Replacement System. The inspection revealed two significant issues related to design controls, specifically concerning inadequate documentation of design input requirements and design risk analysis results. These findings indicate deficiencies in the firm's adherence to medical device design control regulations.