Day

March 8, 2017
Company:Medtronic Neuromodulation Date of Enforcement Report 3/8/2017 Class l PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Recall Number Z-0788-2017 REASON Medtronic is following...
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Company: Mckesson Medical Imaging Date of Enforcement Report 3/8/2017 Class lI: PRODUCT McKesson Radiology 12.2 – Picture Archive Communication System (PACS). Recall Number Z-1245-2017 REASON Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a...
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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

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