eCordum, Inc. – FDA 483, Jul 12, 2023

An FDA inspection of eCordum, Inc. in Amherst, MA, a medical device specification designer, revealed numerous significant deficiencies in its quality system. The firm lacks established procedures and documentation for critical areas including medical device reporting, corrective and preventive actions, complaint handling, and various stages of design control. These observations indicate a fundamental absence of a robust quality management system for medical device development.