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.


Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

Partners located in the US (CA, FL, MA, MN, TN) and Italy.