Day

March 6, 2010
Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain....
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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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