29 件 ・ 関連度順
概要と使いどころ
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.
日本語の概要は準備中です。原文の説明を表示しています。
Your healthcare and life sciences brain trust. 25 named personas across 7 cells covering drug discovery, medtech, biotech strategy, health policy, genomics, clinical trials, and healthcare economics.
日本語の概要は準備中です。原文の説明を表示しています。
Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations — dated, verified, and sized per event for any medtech ticker or watchlist.
日本語の概要は準備中です。原文の説明を表示しています。
Shared review framework that every domain reviewer (pci, oracle, gov, edtech, healthcare, mlops, etc.) MUST follow. Defines the output artifact (TM-{slug}.md), mandatory sections, severity scale, verdict format, the workflow scaffold (when-invoked, Step-0 read-inputs, HANDOFF), and the "domain heuristic vs generic check" boundary. Eliminates duplication across the ~30 reviewer prompts.
日本語の概要は準備中です。原文の説明を表示しています。
Evaluate edtech tools for their real impact on teacher time and administrative burden.
日本語の概要は準備中です。原文の説明を表示しています。