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IEC 62304 medical device software lifecycle framework. Risk classification, software safety classification (A/B/C), design control, verification, validation, and regulatory documentation for FDA/EU MDR submissions.
Audit a rehabilitation or physical therapy platform end-to-end -- evaluate recovery metrics tracking (ROM, strength, balance, gait), patient-reported outcomes (DASH, LEFS, NDI, ODI, PROMIS), home exercise program personalization and compliance tracking, setback prediction with risk stratification...
Analyzes expert witness reports, depositions, and testimony to identify gaps in medical record review, map conflicts to the full record set, and produce impeachment and admissibility analysis with pinpoint citations. Use when reviewing expert reports for missing medical records, selective review ...
当用户需要协助理赔沟通时使用此 skill。适用于理赔申请指导、与保险公司沟通话术、理赔异议处理等场景。
Analyze medical billing and revenue cycle management software including claims processing pipelines, EDI transaction handling (837P/837I/835/270/271/276/277), ICD-10 and CPT code validation with NCCI edit checking, payer rules engine configuration, denial management and appeal workflows, prior au...
Cross-species cancer research linking spontaneous canine/feline tumors to human cancer mechanisms and therapeutic targets. Bridges veterinary and human oncology for co-discovery and translational medicine.
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing require...
Guidelines for clinical decision support (CDS) documents: biomarker-stratified cohort analyses and GRADE-graded treatment reports. Covers structure, executive summaries, evidence grading (1A–2C), stats (HR, CI, survival), and biomarker integration. Use for pharma research docs, clinical guideline...
Automated 510(k) premarket notification preparation for generating submission packages, predicate device comparisons, and substantial equivalence arguments
Design Failure Mode and Effects Analysis (DFMEA) skill for systematic design risk identification
AI-powered cytokine release syndrome (CRS) and cytokine storm analysis for prediction, monitoring, and management in immunotherapy and infectious disease.
AI-powered analysis for predicting optimal immune checkpoint inhibitor combinations based on tumor microenvironment, biomarkers, and molecular profiling.
Precision Oncology
Expert-level medicinal chemistry knowledge. Use when working with drug design, structure-activity relationships, ADMET properties, pharmacophores, lead optimization, target identification, drug metabolism, or pharmaceutical development. Also use when the user mentions 'SAR', 'drug design', 'pharm...
Determine the appropriate FDA premarket pathway for an AI-enabled medical device based on intended use and predicate landscape
Cancer Therapy Design - Design cancer therapy: identify targets, find drugs, check safety, and analyze differential expression. Use this skill for oncology tasks involving get associated targets by disease efoId get associated drugs by target name get adverse reactions by drug name tcga different...
Medical device software development covering IEC 62304 software lifecycle, ISO 14971 risk management, design controls, software verification and validation, FDA regulatory submissions, software change control, and cybersecurity for medical devices.
Plan medical device development with 510k/PMA. TRIGGERS - Use when user needs help with medical-device-plan related tasks.
Develop and maintain clinical decision support rules including alerts, reminders, order sets, and evidence-based recommendations within EHR systems
Map clinical study data to FDA Substantial Equivalence and clinical performance criteria for AI-enabled medical devices
Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
Systematic literature review skill for clinical evaluation supporting regulatory submissions
Clinical study design skill for medical device trials including IDE studies and post-market studies
DICOM conformance testing and integration skill for medical imaging systems
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