Korean KFDA Draft Software Guidelines

This link contains an August 2007 draft Korean KFDA guideline entitled “Medical Software Evaluation Guidelines.” This guidance focuses on examining information about the software and what it does, rather than how it may fail or risk management for those failures. There is significant emphasis and specificity in revision numbering and change control. Korea KFDA Software Guideline

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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