NIST Statistical Data Sets Useful for Validation

The National Institute of Science and Technology publishes data sets and solutions which can be useful for validation of applications used in FDA regulated industry. These data sets provide input data and expected results for a variety of statistics including regression analysis and ANOVA. A link to the relevant NIST web pages providing this data is provided.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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

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