Walter Graphtek Germany EEG devices

Walter Graphtek Germany 7/1/96 EEG devices

3. Failure to perform planned and periodic audits in accordance with written procedures by appropriately trained individuals not having direct responsibility for the matters being audited, as required by 21 CFR 820.20(b). For example, the following areas were identified as having not been audited under your internal quality assurance program: software validation (device and production test), calibration, and engineering change processes.

6. Failure to have specification changes approved and documented by a designated individual(s), including an approval date and the date the change becomes effective, as required by 21 CFR 820.100(a)(2). For example, there are no formal change control procedures to control device engineering changes and to provide written approvals for such changes. Also, failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). For example, more than [purged word] changes have been made to the device software since 1987, however, no validation information existed and no written software specifications existed for even the latest version.

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:

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