483
Mindways Software, Inc.FDA 483 - Mindways Software, Inc. - March 05, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Mindways Software, Inc. in Austin, TX, a class II medical device manufacturer, was cited by the FDA for failing to establish adequate procedures for design changes. Specifically, the firm lacked requirements for software compilation and bug mitigation for their densitometer functionality software. This indicates a deficiency in their quality system for software development and control.
- Office
- Dallas District Office
- Person
Open in Dashboard
ID · f66d6dc8-2412-4180-9a8b-d81d12410d27