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

“Being Agile & Compliant”

2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019

Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!

Hurry to get latest discounts … submit form below:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.