卖什么
监管科技。
商业模式拆解
买家：谁掌握预算？
未核实Regulatory/quality heads or founders at MedTech and IVD companies (hypothesis).
触发点：什么让他们现在购买？
Need for CE marking under MDR/IVDR with regulatory uncertainty, fragmented documents and unpredictable cost/timelines.
工作流：什么输入变成什么输出？
Three services: Regulatory Compass (qualification, classification, pathway), Technical File Readiness (technical documentation, clinical evidence, labelling, consistency checks), Lifecycle Compliance (monitoring, change impact, post-market surveillance); AI drafts, expert reviews.
经济账：省了什么，怎么收费？
Fixed-cost, defined-timeline services.
渠道：怎么接触到客户？
Demo booking.
融资历史与报道
| 融资日期 | 轮次 | 金额 | 投资方 | 来源 |
|---|---|---|---|---|
| 2026-10-06 | 种子前 | €150K | — | news.google.com |
档案汇总自公开报道和公司官网。商业模式部分是 MaxBC 对这些材料的解读，不是已确认的事实；未知之处留空，不作猜测。 更新于 2026-10-12.