Stratec Medizintechnik Gmbh

Recipient: Stratec Medizintechnik Gmbh
Product: bone densitometer.
Date: 9/10/2008

Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e). For example:
The printouts contained in the DHR derived from computer software used to calibrate and test the finished device do not include the name of individual or contain the signature of the individual who performed the test and evaluated the results.

CDRH

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.

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