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October 24, 2013
This SoftwareCPR.com newsletter lists items added to the website from 7/22/2013 to 10/24/2013. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related web page should...
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If sample sizes need to be determined there are many statistical methods and assumptions related to this so decisions should be carefully considered. Two of the most commonly used sample tables are ISO 2859 for attibutes and ISO 3951 for variables.
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The amendments to ISO 62366 and IEC 60601-1-6 were approved unanimously. The amendment to 62366 introduces requirements for legacy products that were created prior to the adoption of ISO 62366 and the amendment to 60601-1-6 clarifies the elements of the usability engineering process that are required for compliance with the IEC 60601 series
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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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