Day

July 10, 2019
Health Canada released the full guidance document, Pre-market Requirements for Medical Device Cybersecurity. It can be viewed at:  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity.htm It includes requirements such as: “Risk management is required for all medical devices throughout their life-cycle. Manufacturers should incorporate cybersecurity into the risk management process for every device that consists of or contains software. Manufacturers are...
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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
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