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
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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...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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