Medical Device Quality Systems Manual: A Small Entity Compliance Guide - First Edition (Supersedes the Medical Device Good Manufacturing Practices Manual - FDA 97-4179)
医疗器械质量体系手册:小型实体合规指南——第一版(取代《医疗器械良好制造规范手册》——FDA 97-4179)
The long-awaited successor to FDA's Medical Device Good Manufacturing Practices Manual. By FDA's Division of Small Manufacturers Assistance. Provides guidance for manufacturers seeking to meet the requirements of the agency's quality system