FDA Mobile Medical Apps Web page

FDA maintains a webpage regarding its apporach to regulation of mobile medical apps. This is at the link provided. There have been many comments on the original guidance and the US congress directly discussed delaying the final and possibly working on legislation related to Health IT and FDA scope in general. Keyword: mobile app

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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