Day

September 30, 2009
Company:Perkin Elmer.Date of Enforcement Report 9/30/2009 Class:ll PRODUCT a) Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1905-2009; b) Specimen Gate Lab – MSMS Data Suite,...
Read More
Company:Hitachi Medical Systems America Inc., .Date of Enforcement Report 9/30/2009 Class:ll PRODUCT 1) EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Recall # Z-2054-2009; 2) EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.