FDA CBER 1994 BECS Manufacturer Letter

This letter was issued at the point FDA ramped up regulation of Blood Establishment Computer Systems as medical devices. It informs manufacturers of such system that they need to comply with all medical device manufacturer regulations and provide premarket submissions for 510(k) clearance of such devices. The letter defines the types of functionality that would be considered as a medical device.

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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