# FDA 483 - Mindways Software, Inc. - March 05, 2025

Source: https://www.globalkeysolutions.net/records/483/mindways-software-inc/f66d6dc8-2412-4180-9a8b-d81d12410d27

> FDA 483 for Mindways Software, Inc. on March 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mindways Software, Inc.
- Inspection Date: 2025-03-05
- Product Type: device
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.globalkeysolutions.net/companies/mindways-software-inc/81d9e779-48b6-41cf-bac0-73a294a38996

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9