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...Read More
Company:RaySearch Laboratories AB Date of Enforcement Report 1/25/12 Class ll: PRODUCT RayStation Version 220.127.116.11 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...Read More
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...Read More
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.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 firstname.lastname@example.org for more info.