by affaan-m
hipaa-compliance is the HIPAA-specific entrypoint for healthcare privacy and security work. Use the hipaa-compliance skill when a task is explicitly about PHI, covered entities, BAAs, breach posture, or whether a workflow creates HIPAA exposure. It is a thin overlay for fast compliance triage and guidance.
by affaan-m
healthcare-emr-patterns is a practical skill for EMR/EHR design in Healthcare. It covers patient encounter workflows, clinical note-taking, medication checks, lab result highlighting, audit trails, CDSS integration, and accessibility-first medical data entry for safer clinician workflows.
by affaan-m
healthcare-eval-harness is a patient safety evaluation harness for healthcare app deployments. It helps teams verify CDSS accuracy, PHI exposure, data integrity, clinical workflow behavior, and integration compliance before release. Critical failures block deployment, making it useful for healthcare-eval-harness for Model Evaluation and CI safety gates.
by affaan-m
healthcare-cdss-patterns helps backend developers build deterministic CDSS logic for medication checks, dose validation, clinical scoring, and alert severity. It favors pure-function decision engines for EMR-adjacent workflows, making patient-safety rules easier to test, validate, and integrate.
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
risk-management-specialist helps AI agents draft ISO 14971:2019 medical device risk work products, including plans, hazard analyses, FMEA tables, risk controls, residual risk summaries, and post-production review inputs. Includes references, templates, and helper scripts for Regulatory Affairs and Quality workflows.
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
qms-audit-expert is an ISO 13485 internal audit skill for medical device QMS teams. It supports risk-based audit planning, clause checklists, nonconformity classification, CAPA verification, external audit prep, and schedule optimization using included references and a Python tool.
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 alirezarezvani
iso13485-audit-prep is a GitHub skill for ISO 13485 QMS compliance review. It pressure-tests DHF, CAPA, complaints, supplier controls, management review, and post-market evidence before audits, MDR/FDA QSR checks, launches, or CAPA follow-up.
by alirezarezvani
fda-qsr-audit-prep is a Compliance Review skill for FDA medical-device QSR audit readiness. Use it to pressure-test complaint files, MDR decisions, CAPA links, process validation, Form 483 responses, and QMSR transition evidence with six inspection-style questions.
by K-Dense-AI
iso-13485-certification helps medical device teams prepare ISO 13485:2016 certification documentation. Use it for gap analysis, Quality Manual drafting, required procedures, work instructions, Medical Device File content, and audit prep. It is especially useful for technical writing and certification-ready QMS 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.
by K-Dense-AI
The clinical-decision-support skill generates publication-ready CDS documents for pharma, clinical research, and evidence synthesis. Use it for biomarker-stratified patient cohort analysis, treatment recommendation reports, and decision algorithms with GRADE-style reasoning, statistical framing, and LaTeX/PDF output. Best for structured clinical decision support, not bedside care.
