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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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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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