Tag

defects
Company:Alaris Products, FDA News FOR IMMEDIATE RELEASE P06-119 August 28, 2006 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA United States Marshals Seize Defective Infusion Pumps Made by Alaris Products Pumps Can Deliver Excess Medication and Harm Patients At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the...
Read More
An article in the August 22, 2003, Los Angeles Times by Charles Ornstein and Tracy Weber, Times Staff Writers, describes an incident where “two patients die after alarms fail”. Read article:  LATimesarticle822
Read More
1 2 3

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@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) and Italy.