123건 · 관련도순
Prepare medical device regulatory strategies and submission documents for FDA, EU, and other markets. Compare application routes, organize technical and clinical evidence, draft responses to regulator questions, and track submission schedules.
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Prepare for FDA medical device quality audits through six evidence-focused questions. Review complaints, adverse event reports, process validation, manufacturing records, corrective actions, labeling, and inspection history, then organize readiness gaps and three next actions with owners.
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Prepare medical device regulatory work for the US FDA. Compare submission routes, organize required documents, review quality management requirements, assess patient data safeguards under HIPAA, and plan device cybersecurity documentation and controls.
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Query the FDA's public openFDA APIs for post-market drug data — FAERS adverse-event reports, Drugs@FDA approval and submission history, Structured Product Labels including boxed warnings, the National Drug Code directory, recall enforcement reports, and drug shortages. Use this skill to check what a regulator has already concluded about a molecule or its class, to date an approval and count its efficacy supplements, to read an approved indication or boxed warning, and to score a drug-event pair for disproportionate reporting with PRR, ROR, and chi-squared. Also trigger on openFDA, api.fda.gov, FAERS, Drugs@FDA, SPL, NDC, pharmacovigilance, boxed warning, adverse event report, drug recall, or safety signal.
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Reconstructed reference notes on US FDA medical-device software regulation, built from seven public-domain FDA sources (the QMSR final rule 89 FR 7496, FDA device software guidance documents, and the eSTAR program page; pinned 2026-10-12). Use for regulatory pathways and premarket submissions (510(k), De Novo, PMA, eSTAR), premarket software documentation levels (Basic or Enhanced), software validation and Computer Software Assurance, the Quality Management System Regulation (QMSR, 21 CFR 820), medical-device cybersecurity (secure product development, SBOMs, FD&C Act section 524B, labelling), clinical decision support boundaries, off-the-shelf software, MDDS and other software-function scope questions, and the 510(k) software-change trigger. SCOPE LIMITS: US FDA device regulation only; no EU MDR or UKCA content (see `med-device-eu`); no ISO 13485, ISO 14971, or IEC 62304 text, which are named and summarized only as FDA obligations; no drug, biologic, or combination-product rules; reflects the pinned source dates, not later FDA actions; synthesized reference notes, not legal advice and not a substitute for the guidance documents. LICENCE: Public Domain (US Government work, 17 U.S.C. 105).
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Query, search, and download data from the openFDA API for drugs, devices, foods, tobacco, cosmetics, animal and veterinary products, substances, and transparency data. Use for FDA adverse events, recalls, labeling, approvals, shortages, 510(k) clearances, NDC lookups, and any FDA safety or regulatory data query across all 28 API endpoints.
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FDA regulatory consultant for medical device companies, covering 510(k)/PMA/De Novo pathways, QSR (21 CFR 820), HIPAA, and device cybersecurity. Use for FDA submissions, predicate and substantial-equivalence analysis, and premarket strategy.
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Prepares medical device quality systems for ISO 13485 audits using six focused questions. Reviews design records, corrective actions, process validation, risk files, post-market monitoring, and management reviews, then summarizes readiness gaps and three priority actions.
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Query openFDA API for drugs, devices, adverse events, recalls, regulatory submissions (510k, PMA), substance identification (UNII), for FDA regulatory data analysis and safety research.
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Query openFDA API for drugs, devices, adverse events, recalls, regulatory submissions (510k, PMA), substance identification (UNII), for FDA regulatory data analysis and safety research.
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Drug regulatory and approval research — FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways. Use for jurisdiction-aware approval status (FDA vs EMA), generic vs brand availability, exclusivity expiry tracking, and regulatory pathway selection. Always specifies the market when reporting status.
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제조 현장의 규격 부적합품에 대해 격리, 원인 분석, 처분 검토, 시정·예방 조치의 효과 확인을 정리하고 관리도 해석과 공급업체 품질 개선을 지원합니다.
Support drug discovery research by searching public databases for compound activity, molecular properties, drug interactions, and gene–disease associations. Assess drug-likeness, meaning how molecular properties fit established rules for potential oral medicines.
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Search biomedical papers, regulatory documents, clinical trials, and protein records through GXL Paperclip. Extract comparable information across documents, inspect figures, and organize findings with citations linked to the source lines that support them.
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Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.
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Calculates tumor mutational burden from WES/WGS/panel data with Friends of Cancer Research harmonization equations, per-assay calibration (FDA 10/Mb = 7.8 TSO500 = 8.4 OncomineTML), synonymous/indel/germline filtering, hypermutator tiering, blood TMB, and integration with HLA-LOH and neoantigen quality (Luksza 2017 fitness). Use when assessing ICI eligibility under tumor-specific cutoffs (McGrail 2021), comparing tissue vs bTMB, or auditing TMB-H reporting against ESMO 2024 and FDA pembrolizumab pan-tumor 2020.
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Designs Bayesian clinical trials including Phase I dose-finding (BOIN, CRM, EWOC, mTPI-2), meta-analytic-predictive (MAP) priors with robust mixtures for external data borrowing, EXNEX for basket trials, hierarchical models for safety AE (Berry-Berry), Bayesian platform trials (I-SPY 2, GBM AGILE, REMAP-CAP), and posterior probability stopping rules. Covers FDA Bayesian Devices Guidance (2010), FDA Bayesian Methodology in Drugs Draft (January 2026), BOIN Fit-for-Purpose qualification (December 2021), and Project Optimus dose-optimisation. Use when designing dose-finding studies, platform trials, or sensitivity analyses with informative priors.
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Designs adaptive clinical trials including group-sequential (O'Brien-Fleming, Pocock, Lan-DeMets spending), sample-size re-estimation (blinded Friede-Kieser, unblinded Cui-Hung-Wang, Mehta-Pocock promising zone), seamless Phase 2/3 with treatment-arm selection, population enrichment, and response-adaptive randomisation. Covers FDA 2019 Final Adaptive Designs Guidance, FDA 2022 Master Protocols, and ICH E20 Step 2b/3 draft (June 2025, NOT final). Use when planning interim analyses, sample-size re-estimation, or master/platform-trial designs.
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Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.
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Query FDA drug approvals, labels, and adverse event databases
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Query FDA drug labels (DailyMed) via REST API. Search structured product labels (SPLs) by name, NDC, set ID, or RxCUI; get indications, dosage, warnings, adverse reactions, packaging. No auth. For adverse events use fda-database; for DDIs use ddinter-database.
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Query openFDA REST API for adverse events (FAERS), labeling, product info, recalls, enforcement. Search by drug name, ingredient, MedDRA, or NDC. 1k req/day no key; 120k with free key. For trials use clinicaltrials-database-search; for structures use drugbank-database-access or chembl-database-bioactivity.
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Vaccine catalyst analysis across the two-gate path: CBER BLA review and the ACIP recommendation gate that turns FDA approval into commercial availability. Lot release, procurement milestones, pediatric bridging, and healthy-population efficacy context — dated, verified, and sized per event.
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Designs Bayesian clinical trials including Phase I dose-finding (BOIN, CRM, EWOC, mTPI-2), meta-analytic-predictive (MAP) priors with robust mixtures for external data borrowing, EXNEX for basket trials, hierarchical models for safety AE (Berry-Berry), Bayesian platform trials (I-SPY 2, GBM AGILE, REMAP-CAP), and posterior probability stopping rules. Covers FDA Bayesian Devices Guidance (2010), FDA Bayesian Methodology in Drugs Draft (January 2026), BOIN Fit-for-Purpose qualification (December 2021), and Project Optimus dose-optimisation. Use when designing dose-finding studies, platform trials, or sensitivity analyses with informative priors.
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