LLC Quality Electrodynamics

Quality Electrodynamics, LLC..
Product: cois used in conjunction with MRI scanners .
Date: 4/10/2015

Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically,

The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings were not documented. Therefore, it is unknown if you are currently operating the reflow oven within your validated parameters.

Your response dated March 26, 2015 cannot be assessed at this time. The response states that you have placed all 176 oven reflow profiles under the change control process and revised your ?Validation of Processes and Software? procedure, SOP 021; and training is ongoing. You are also working with an SMT (Surface Mount Technology) expert to aid in monitoring the process capability and control of the SMT line. Additionally, you have ordered new process monitoring equipment. Please provide an update on the progress of these corrective actions.

FDA District Office: Cincinnati District

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email to start a conversation.  We can provide estimates of cost and support your development tools.

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