Recipient: 3CPM, Inc.Product: electrogastrogram (EGG) devices Date: 325/10 6. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: b. When requested, no evidence that the changes made to the finished device or...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.