Day

October 30, 2009
Health Canada now indicates that patient management software fits the definition of a medical device. “Any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device based on Rule 12 of the Medical Devices Regulations.”
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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

Email office@softwarecpr.com
for more info!

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15148 Springview St
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Partners located in the US (CA, FL, MA, MN) and Italy.