FDA Image Management Classification Rule

FDA CDRH’s 21 CFR 892 Radiology Devices: classification of Five Medical Image-management Devices (MIMS). This classification regulation is related to picture archiving and communication systems (PACS) and various types of image-management, communications, and storage devices and defines which types of devices are exempt from 510(k) submissions. Note there was a correction issued on August 24, 1998 for this rule.

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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