January 27, 2012
The UL 1998 revision comment period ends March 5, 2012. The suggested revisions include: Reducing ambiguity in the applicability of the requirements for Negative Condition Branch failure mode and stress testing Revision of requirements to address the effects of power supply voltage variations Revised formating of Table A2.1 to clarify acceptable measures for each requirement...
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Company:RaySearch Laboratories AB Date of Enforcement Report 1/25/12 Class ll: PRODUCT RayStation Version Consult instruction for use. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to...
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Company:CareFusion 209 Inc Date of Enforcement Report 1/25/12 Class ll: PRODUCT NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review...
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The Joint Initiative on SDO Global Health Informatics Standardization is formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts.
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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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  • Software risk analysis
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  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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