Day

November 7, 2005
Recipient: Visual Telecommunications NetworkProduct: ViTelCare Trutle Home Patient Monitoring Systems Date: 9/13/05 Software used in the Turtle 600 and Turtle 800 devices has not been validated and a risk analysis has not been conducted for the finished devices [21 CFR 820.30(g)]. FDA District: Baltimore District Office
Read More
http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htm
Read More
Recipient:Guidant CorpProduct: TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer Date:9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended...
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 training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.