Day

February 25, 2015
Company:CME America, LLC.Date of Enforcement Report: 2/25/2015 Class lI: PRODUCT BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP Recall Number Z-1126-2015 REASON CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. RECALLING FIRM/MANUFACTURER CME America, LLC, Golden, CO on 1/16/2015 Voluntary: Firm...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/25/2015 Class lI: PRODUCT Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose...
Read More
Company:Alivecor SFO.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG...
Read More

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.