June 12, 2013
Company:Symbios Medical Products.Date of Enforcement Report 6/12/2013 Class I: PRODUCT Part 510031 Disposable Single Infusion Pump, quantity Includes… TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO… found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 – BP, w/ Epidural...
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Company: American Optisurgical.Date of Enforcement Report: 6/12/2013 ClassL Ill: PRODUCT Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. Recall Number Z-1441-2013 REASON Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different...
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Company: American Optisurgical. Date of Enforcement Report: 6/12/2013 Class ll: PRODUCT American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Recall Number Z-1516-2013 REASON The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board....
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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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