Day

February 4, 2009
The Carnegie Mellon Software Engineering Institute performs a number of research projects each year. Their december report on these projects is at the link provided. One of the projects was on safety cases for medical devices. Sherman Eagles of SoftwareCPR and Paul Jones of FDA participated in this project.TECHNICAL REPORT CMU/SEI-2008-TR-025 ESC-TR-2008-025 SEI assurance case...
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These two draft standards for networked medical devices and for medical device software risk management have been renumbered IEC 80001-1 and IEC 80002-1 respectively. IEC 80002-1 was released for a 3 month ballot period Jan 16, 2009.
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Company:GE Healthcare Integrated IT Solutions. Date of Enforcement Report 2/4/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout...
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Company: iCAD, Inc. Date of Enforcement Report 2/4/2009 Class:ll PRODUCT a) CAD SCIENCES LLC 3 TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. Recall # Z-0653-2009; b) CAD SCIENCES LLC 3 TP PrecisionPointTM Software, for biopsy guidance. Recall # Z-0654-2009; REASON Software modules not approved for this indication. RECALLING...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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