医疗器械投标专属 AI Agent

57 合规风险。
1 响应速度。

上传招标参数,分钟级导出合规标书。MedStrato 为您自动完成所有繁琐的合规核对工作。

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Extract
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Comply
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Submit
Extracting...
fx
=EXTRACT_REQUIREMENTS(TenderDoc.pdf, "technical")

Scanning Tender Document...

Parsing 164 technical nodes from World Bank Master Spec

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Premium Color Doppler Ultrasound System with 21.5" High-Res LED Monitor
Fully digital beamformer with > 2,000,000 digital processing channels
Scanning depth up to 40cm with automatic acoustic power adjustment
Support for Single Crystal Convex and high-frequency Linear transducers
DICOM 3.0 Full implementation: Store, Print, Worklist, MPPS, Query/Retrieve
Real-time Elastography with quantitative analysis tools
Tissue Harmonic Imaging (THI) and Pulse Inversion Harmonic
Battery backup supporting at least 60 minutes of continuous scanning
Integrated barcode scanner for rapid patient data entry
System must weigh under 65kg for easy mobility
FDA 510(k) clearance or CE marking under MDR conformity
5-year comprehensive warranty covering parts, labor
MedStrato Engine v2.4
Pipeline: Extract
Audit Precision
Computing
ISO 27001 SOC2 Platinum
GDPR / HIPAA Governed
Global YC Network
AI Tender Software

MedStrato 工作原理

AI Logic Matching

Technical Audit Node

Live Trace
RequirementDetected SpecStatus
Operating Voltage100-240V AC
Device WeightMax 12 kg
Display SizeMin 15"
Battery Life> 2 hours
IP RatingIPX4 min
DICOM 3.0Required
Verified against Doc_ID: #XF-902...

映射

上传标书。即时提取并结构化所有技术要求。

Trust Engine

Multi-Regional Governance

0/5
ISO-13485Quality Management
Pending
IEC-60601Electrical Safety
Pending
HIPAAData Privacy
Pending
GDPREuropean Access
Pending
SOC2-TypeIISecurity Controls
Pending
Global ReadySecure Protocol 4.2

匹配

将参数与需求精准匹配,实现 100% 来源溯源。

Package Assembly

Compiling output files...

Technical_Part_R11.xlsx2.4MB · 28 pages
Compliance_Matrix_v4.pdf840KB · 14 pages
Executive_Summary.docx1.2MB · 6 pages

导出

扫描漏洞、验证每一行,并导出您的中标方案。

Why MedStrato

专为医疗器械团队打造

溯源匹配

每项参数匹配均直接关联至产品文档的精确页码和行号。拒绝黑盒 AI。

内置合规

提交前自动标记合规缺口,按严重程度分类。您的团队审核确认,而非 AI 决定。

一键响应

以原始格式生成完整标书。导出 Excel、PDF 或 Word,附带完整审计记录。

常见问题

引擎读取文件,提取需求,并与您的目录交叉比对。每项匹配均有据可查。

95% 以上的参数准确率。AI 负责繁重工作,您的团队做最终决策。

是的。AES-256 加密。SOC2 就绪。绝不用于 AI 训练。

分钟级匹配。完整的团队入职通常仅需一天。

Excel, PDF, Word。原始格式导出,无需重新排版。

有。14 天全功能免费试用。无需信用卡。

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预约演示
SOC 2 Type II
HIPAA
GDPR