October 27, 2004
The following question was asked during the “Ask the FDA” session (326-QE) on 10/25/04 at the AABB Annual Meeting held in Baltimore, MD as reported by SoftwareCPR Partner Molly Ray: When blood establishment computer software manufacturers distribute their device (software) for beta testing, they are required to label the software in accordance with the IDE...
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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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Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.