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,...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.