FDA Issues Computer Software Assurance Guidance: A Paradigm Shift in Medical Device Quality Systems
What is Maintaining Validation Status?
FDA CSA Draft Guidance with Bilingual Translation
[Preliminary] FDA’s Draft CSA Guidance Issued on September 13, 2022.
About Blind Compliance
CSA & Critical Thinking
General Principles of Software Validation; Final Guidance for Industry and FDA Staff 対訳表
CSA（Computer Software Assurance）セミナー 2章（サンプル）
CSA（Computer Software Assurance）セミナー 1章（サンプル）
CSA（Computer Software Assurance）セミナー 3章（サンプル）
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