Day

July 30, 2014
Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/302014 Class lI: PRODUCT Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment...
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Company:Philips Ultrasound, Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2110-2014 REASON Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0...
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Company:Philips Ultrasound, Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2109-2014 REASON Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0...
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Company:Hospira Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or...
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Company: Invacare CorporationDate of Enforcement Report: 7/30/2014 Class lI: PRODUCT MK5 NX Controller–Wheelchair controller Recall Number Z-2091-2014 REASON M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward...
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Company: GE Healthcare Date of Enforcement Report:7/30/2014 Class I: PRODUCT DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. Recall Number Z-2068-2014 REASON Failure of the CO2 detector in...
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Company: GE Healthcare Date of Enforcement Report:7/30/2014 Class lI: PRODUCT GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Recall Number Z-2085-2014 REASON GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data...
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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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