April 1, 2019 FDA & ISO DMR/MDF vs. “Design Output” Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding blog post). It unequivocally lives and breathes in direct relationship to the design control process. A properly-maintained DMR never becomes decoupled […]
<h1 class="entry-title">Category: Design & Development</h1>
FDA & ISO 13485 Design Outputs and the DMR
FDA & ISO 13485 Design Outputs and the DMR Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, “…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. […]
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