October 16, 2018
Company: AS Software, Inc Date of Enforcement Report 10/24/2018 Class II: PRODUCT AS-OBGYN Information System version 7.824.x Recall Number: Z-0118-2019 REASON Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that...
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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

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