Day

May 7, 1999
07
May

Picker MRI Equipment

May 7, 1999
Picker 7-May-99 MRI equipment The following, deviations from the Device Quality System Regulations were documented: 1) Failure to maintain a design file necessary to demonstrate that the design was developed in accordance with the approved design plan as required by 21 CFR 820.30(j). For example, there is no documentation of any module testing of the...
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