Day

June 13, 2014
See the ONC 10-year roadmap to achieving a “learning health system” based on an interoperable health IT ecosystem at the link provided. ONC 10 year Interoperability Concept Paper
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A number of draft standards were released for comment, including including several related to specific security for medical devices and Health IT: AAMI TIR38 – AAMI Medical device safety assurance case guidance IEC Health SW Standards Framework ISO 27799 Health informatics “Information management in health using ISO/IEC 27002” IEC TR 80001-2-8, Application of risk management...
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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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