Transplantation Research Foundation

Company: Transplantation Research Foundation
Date: 6/25/01
Product Name: Dura mater allografts

Failure to establish and maintain procedures to control product that does not conform to specified requirements [21 CFR 820.90]. For example, the computer disposition records did not clearly document the destruction of unsuitable dura mater, and there are no disposition procedures addressing the segregation and disposition activities for unsuitable dura mater [FDA-483 Item 6(a)].

FDA District: Dallas

SoftwareCPR keyword: electronic records

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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