by alirezarezvani
clinical-research helps teams design prospective clinical studies before submission, with endpoint classification, two-arm sample size and power estimates, and feasibility phase-gate scoring. It includes Python tools, references, and a protocol synopsis template, while keeping outputs as estimates for clinician, biostatistician, and regulatory review.
by alirezarezvani
regulatory-affairs-head is a Claude skill for medical device and HealthTech regulatory planning, including FDA 510(k), De Novo, PMA, EU MDR technical documentation, CE marking, global pathways, ISO mapping, deficiency responses, and submission tracking with included references and scripts.
by alirezarezvani
mdr-745-specialist is an EU MDR 2017/745 compliance skill for device classification, Annex II/III technical documentation, clinical evidence, PMS/PMCF/PSUR planning, and notified body readiness. It includes MDR reference guides and a Python gap analyzer for structured compliance review.
by K-Dense-AI
The treatment-plans skill helps generate concise, clinician-focused medical treatment plans in LaTeX/PDF-ready form. It supports general medicine, rehabilitation, mental health, chronic disease, perioperative care, and pain management with SMART goals, evidence-based interventions, minimal citations, and compliance-aware formatting. Ideal for treatment-plans for Technical Writing and structured care documentation.
by K-Dense-AI
clinical-reports is a structured writing skill for clinical case reports, diagnostic reports, clinical trial reports, and patient documentation. It supports CARE, ICH-E3, HIPAA, FDA, and ICH-GCP workflows, with clear templates and guidance for accurate, de-identified, publication-ready clinical writing.
