Day

May 5, 2014
This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. Green Paper on Mobile Health
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The following draft standards are being circulated for comment or ballot. More information is availale to Standards Navigator Subscribers in the the Standards Navigator topic:-IEC 62304 Amendment CDV -$ISO 16142-1 DIS -ISO 90003 FDIS -ISO 15289 FDIS -ISO 24748-4 DIS -ISO 24748-6 NP
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This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. BSI WP EU Regulations
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Alan Kusinitz Managing Partner of SoftwareCPR accepted appointment to the Biomedical Instrumnetation and Technology journal editorial board. Alan authored a number of articles for this journal and performed peer revieiws for the journal over the years.
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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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