Day

September 6, 2018
Company: Hitachi Healthcare Americas Corp Informatics Division. Date of Enforcement Report 9/12/2018 Class II: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study....
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Company:Hitachi Healthcare Americas Corp Informatics Division.Date of Enforcement Report 9/12/2018 Class lI: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study. RECALLING FIRM/MANUFACTURER...
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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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