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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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