# FDA 483 - S.M.A.I.O - September 19, 2024

Source: https://www.keypedia.com/records/483/smaio/29da26e5-adc0-46d6-b94a-186d341599dc

> FDA 483 for S.M.A.I.O on September 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S.M.A.I.O
- Inspection Date: 2024-09-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of S.M.A.I.O in Saint-Priest identified significant deficiencies in the firm's design and development activities for its medical device software. The company's software development procedure and product requirements document contained ambiguous, incomplete, or non-measurable design inputs, and a distributed Class II medical device software, "KEOPS Balance Analyzer 3D, version 2.2", was found to lack a completed risk analysis. These issues indicate a failure to adequately establish design plans, potentially impacting the safety and effectiveness of the device.

## Related Officers

- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)

Company: https://www.keypedia.com/companies/smaio/5efdd82b-c3f7-437a-846a-eb66b4999b49

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4