HalseyYang

You can build FDA 510(k)/PMA/De Novo submission packages, generate EU MDR technical documentation and GSPR checklists, run ISO 14971 risk analyses, audit PMS/PSUR documents, clean clinical trial data to CDISC/SDTM standards, and produce PDF, DOCX, XLSX, and PPT deliverables.

Regulatory affairs specialists, quality managers, clinical evaluation writers, and R&D engineers at medical device and pharmaceutical companies preparing FDA, EU MDR, NMPA, or PMDA submissions. Secondary users include consultants producing client-ready reports and presentation decks.

Skills are installed via the skill-install-or-create utility from GitHub, npm/npx commands, or local folders, then triggered by natural-language phrases such as '审核bdd', '生成PPT', or 'MDR 技术文件'. Some skills require LibreOffice, Poppler, or Windows COM for Office export.

Most skills carry an MIT license, including minimax-pdf, minimax-docx, minimax-xlsx, clinical-data-cleaner, fda-bdd-reviewer, and the MedXpert clinical evaluation and STED skills. A few skills omit license declarations, so verify individual folders before redistribution.

Document skills rely on Poppler, reportlab, pdfplumber, python-docx, and LibreOffice for rendering and export; Photoshop and Illustrator harnesses require Windows COM. The csv-documentation-generator needs Python 3.10+, and gov-safety-recalls requires curl or mcporter binaries.