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December 28, 2016
Company: Merge Healthcare, Inc. Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recall Number Z-0878-2017 REASON Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis...
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Company: Radiometer America Inc.Date of Enforcement Report 12/28/2016 Class lI: PRODUCT AQURE System Software Version 2.2.0Model #: 933-599UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor...
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Company: Medtronic Neuromodulation Date of Enforcement Report 12/28/2016 Class lI: PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable...
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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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