Day

October 18, 2017
The EU has proposed a new regulation on cybersecurity.  While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.”  The new tasks include: Facilitating the establishment and take-up of European...
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SoftwareCPR now has a validation blog at the link provided. The latest entry as of 18-Oct-2017 contains some Retrospective Validation Tips provided by SoftwareCPR founder Alan Kusinitz. Earlier entries relate to Part 11, Agile methods, and Health IT. ValidationCPR Blog
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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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