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FDA and NB audit of Engineering Drawings in DHF and DMR.


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I would like to know that during FDA/NB audits, what all points they look for in Engineering Drawings in the DHF/DMR. Not sure that if such requirements are documented anywhere. Thankful to responses in advance

Ronen E

Problem Solver
Staff member
Super Moderator
From a QA perspective the requirement for engineering drawings is that they fully and unambiguously define the design, and the effective revisions are available where needed and when needed, with little effort.
I don't think that NBs or the FDA check engineering drawings from an engineering point of view in routine (not for-cause) audits. It's not their job, unless the regulation requires a design examination (e.g. MDD Annex II s. 4).
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