medical-device-reg-dossier@0.1.4

Publisher claims: "Compile submission-ready medical device registration dossiers by market — China NMPA, US FDA (510(k)/eSTAR), EU MDR, Japan PMDA and global convergence. Compile submission-ready medical device registration dossiers by market — China NMPA, US FDA (510(k)/eSTAR), EU MDR, Japan PMDA and global convergence. Uses the IMDRF STED six-chapter skeleton mapped to each market's annex, producing summary, study report, clinical evaluation and labeling modules, plus classification determination and document checklists. 医疗器械注册申报资料编写助手——按市场结构汇编可提交的注册申报资料：中国 NMPA 注册、美国 FDA注册（510(k)/eSTAR）、欧盟 MDR、日本 PMDA 及全球协调路径。以 IMDRF STED 六章为骨架，映射各市场 Annex 章节，输出综述、研究资料、临床评价、标签等模块，并给出注册分类判定与资料清单梳理。生成后用 medical-device-compliance-grader 的 C1 维度自测。" Observed in sandbox: no network, touches nothing outside the project, writes no memory.