Day

September 21, 2016
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306 Recall Number Z-2799-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Recall Number Z-2798-2016 REASON There is a potential for the first and/or last name of one patient to be...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395 Recall Number Z-2803-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394 Recall Number Z-2802-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393 Recall Number Z-2801-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392 Recall Number Z-2800-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...
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Company: Hospira Inc. Date of Enforcement Report 9/21/2016 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...
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Company: Thermo Finnigan LLC. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Endura MR Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and...
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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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