Day

February 20, 2015
XZeal Technologies, Inc.Product: XZeal Dental X-Ray Unit Z70 Date: 2/20/2015 1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example: b. Your firm has not established and maintained documentation in support of Section 4.6 – Design Validation of the Product – Conception and Development, PR0-04.01,...
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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.

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