Day

September 28, 2016
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images Recall Number Z-2852-2016 REASON Software error. Incorrect values for the volume calculation from a freehand VOI at...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-2853-2016 REASON Software error. Incorrect values for the volume calculation from a freehand VOI...
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Company:Invivo Corporation Date of Enforcement Report 9/28/2016 Class lI: PRODUCT Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.. Recall Number Z-2790-2016 REASON Frozen...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 9/28/2016 Class lI: PRODUCT CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. Recall Number Z-2871-2016 REASON An incorrect...
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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

Need info?  Email us at training@softwarecpr.com

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