![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » HMD Biomedical Faulted for Design Validation
HMD Biomedical Faulted for Design Validation
Taiwan-based HMD Biomedical received a warning letter for inadequate procedures for device design validation, process control, and control of environmental conditions.
An inspection of the company’s facility in March 2016 revealed a failure to establish and maintain procedures for validating device design. In one instance, a software validation test report contained six columns for evaluation of six meters, but only two meters were marked with “OK” test results.
Upcoming Events
-
21Oct