FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

HMD Biomedical Faulted for Design Validation

March 6, 2017
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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.

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