Twelve-skill bundle covering the NEJM clinical manuscript lifecycle: workflow router, clinical-significance fit, study design & trial registration, EQUATOR reporting guidelines, structured abstract, terse IMRAD writing, clinical statistics, clinical display items, clinical ethics & integrity, Vancouver/ICMJE references, submission preflight, and response to reviewers.

14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.

Enterprise / cross-functional Research Operations domain — the managed counterpart to the academic research/ domain. v2.9.0 ships 5 skills: orchestrator (context: fork) + clinical-research (study design: protocol synopsis + endpoint selection + sample-size/power for means/proportions/survival + phase-gate feasibility) + research-finance (R&D program budgeting with F&A split + burn/runway + capital