Day

August 4, 2004
Company: Beckman Coulter, Inc.Date of Enforcement Report: 8/4/04 Class: III PRODUCT DataLink 2000 Data Manager. Version 6.3. Recall # Z-1096-04. REASON Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system. CODE Version 6.3 RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter on November 3,...
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.