Day

May 15, 2019
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/15/2019 Class II PRODUCT Atellica IM 1300 Analyzer, Material Number 11066001; Recall Number: Z-1299-2019 Atellica IM 1600 Analyzer, Material Number 11066000; Recall Number: Z-1300-2019 Atellica Sample Handler Prime, Material Number 11069001; Recall Number: Z-1301-2019 REASON There were multiple issues identified in the system software which required...
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Company: Medtronic Inc. Date of Enforcement Report: 5/15/2019 Class II: PRODUCT Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Recall Number: Z-1282-2019 REASON The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the...
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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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