Day

November 9, 2016
Company: Spacelabs Healthcare Inc Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-0332-2017 REASON The firm received reports of telemetry...
Read More
Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027 Recall Number Z-0354-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...
Read More
Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 Recall Number Z-0353-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...
Read More
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm523316.htm
Read More

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

Corporate Office

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