FDA CBER: BECS & Submission types

FDA’s Center for Biologics Evaluation and Research presentation slides from “Computerizing Collection Centers: FDA Submission and Approval ” presented by Nancy Jensen at ABRA Plasma Forum June 11, 1998. Among other things these slides describe CBER’s application of the new 510(k) Paradigm to Blood Bank Computer System Submissions. This includes requirements for abbreviated and special 510(k)s.

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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