MMApp used with Drugs

Although FDA’s Device Center tends to exempt many Mobile Medical Apps from regualtion FDA’s Drug Center has its own approach. Our current understanding is that mobile apps distributed with drugs are considered part of a combination product in many cases and the Drug Center will review the MMApp information as part of the product approval process.

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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