December 22, 1999
REASON Software may incorrectly link previous assay results to a different patient ID. PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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