MedStrato is an AI-powered platform designed for medical device companies to automate tender response, spec matching, and regulatory compliance monitoring.

Does MedStrato support EU MDR?

Yes, MedStrato has native support for EU MDR 2017/745, including automated compliance checking against MDR requirements and EUDAMED integration.

How accurate is the AI spec matching?

Our semantic matcher achieves over 97% accuracy with a false positive rate under 0.3%, significantly outperforming keyword-based systems.

Orbid is MedStrato's autonomous AI agent for medical device tenders. It reads the tender document, matches products from your catalog, checks every specification for regulatory compliance (FDA, EU MDR, MHRA + 11 more), and drafts a submission-ready bid response — end to end, without manual intervention on mechanical steps.

How is Orbid different from tender management software?

Traditional tender management software helps you organize the bid process. Orbid runs the bid. It's an autonomous agent that processes the entire tender response — from document parsing to final draft — in minutes rather than weeks. Your team reviews and submits; Orbid handles the mechanical work.

將醫療器械招標
變成可提交的文件。

上傳招標書。MedStrato 將每項要求匹配到你的產品規格，拉取證據鏈，輸出完整的應標文件——直接提交，無需返工。

申請存取看看效果 →

MedStrato is a medical device tender automation platform by Galaxias Inc. It turns unstructured medical tenders into submission-ready files using AI-powered spec matching, compliance checking across 14 regulatory regimes (FDA, EU MDR/IVDR, MHRA, TGA), and automated evidence gathering. Key metrics: 162 rows matched in 46 seconds, 0.3% false-positive rate, 1.4M indexed SKUs. Used by procurement teams in 38 countries. SOC 2 Type II certified, HIPAA and GDPR compliant.

R11_Ultrasound_Doppler_Technical_Part1.xlsx
·Imported
Row # = Col A
Requirement = Col B
Required Spec = Col C
Offered Spec = Col D
Notes = Col E
A
B
C
D
E
1
Brand/Manufacturer Name
Bidder to specify
Manufacturer Name
Enter response…
Matched via catalog record
2
Model Name
Bidder to specify
Model Name
Enter response…
—
3
Country of Origin
Bidder to specify
Country of Origin
Enter response…
—
4
Year of 1st Production
Bidder to specify
Year of First Production
Enter response…
—
5
Brochure/Catalogue
Provide in English, soft and hard copy
Brochure/Catalogue
Enter response…
4 files linked
6
Regulatory Approval
NIE or equivalent, US FDA, CE or standard
Regulatory Approval
Enter response…
Evidence: fda.gov/…
7
2-D Ultrasound w/ Doppler
Abdominal, small parts, urology, OB/GYN
Clinical Applications
Enter response…
Covers 4 of 5 required domains
8
Number of Transducer Ports
≥ 3 active connectors
Probe Ports
Enter response…
—
9
Flat Linear Array (FLA)
Required
FLA Transducer
Enter response…
—
10
Convex/Curved Linear (CLA)
Required
CLA Transducer
Enter response…
—
11
Endocavity Transducer
Required
Endocavity Probe
Enter response…
Not in base package
12
B-mode
Real-time 2D imaging
B-mode
Enter response…
—
Ultrasound Doppler
Hazards & Recalls
Accessories
Service Contract

EP500

EP500 · Everlight Medical

#
Requirement
Offered spec
Status

01

Brand/Manufacturer Name

Awaiting

02

Model Name

Awaiting

03

Country of Origin

Awaiting

04

Year of 1st Production

Awaiting

05

Brochure/Catalogue

Awaiting

06

Regulatory Approval

Awaiting

07

2-D Ultrasound w/ Doppler

Awaiting

08

Number of Transducer Ports

Awaiting

09

Flat Linear Array (FLA)

Awaiting

10

Convex/Curved Linear (CLA)

Awaiting

11

Endocavity Transducer

Awaiting

12

B-mode

Awaiting

Match: 0
Partial: 0
Gap: 0
12 unset

Compliance score

● 0 match
● 0 partial
● 0 gap
12 unset

Missing response (12)

Brand/Manufacturer Name

Model Name

Country of Origin

Year of 1st Production

Brochure/Catalogue

Regulatory Approval

2-D Ultrasound w/ Doppler

Number of Transducer Ports

+ 4 more…

R11_Ultrasound_Doppler_Technical_Part1.xlsx· 已匯入 · 工作表: Ultrasound Doppler

Requirement

Required Spec

Offered Spec

Notes

Compliance

Brand/Manufacturer Name

Bidder to specify

[enter response]

—

Model Name

Bidder to specify

[enter response]

—

Country of Origin

Bidder to specify

[enter response]

—

Year of 1st Production

Bidder to specify

[enter response]

—

Brochure/Catalogue

Provide in English, soft and hard copy

[enter response]

—

Regulatory Approval

NIE or equivalent, US FDA, CE or standard

[enter response]

—

2-D Ultrasound w/ Doppler

Abdominal, small parts, urology, OB/GYN

[enter response]

—

Number of Transducer Ports

≥ 3 active connectors

[enter response]

—

Flat Linear Array (FLA)

Required

[enter response]

—

Convex/Curved Linear (CLA)

Required

[enter response]

—

Endocavity Transducer

Required

[enter response]

—

B-mode

Real-time 2D imaging

[enter response]

—

招標書，原始狀態。 12 行 · 40 個標籤頁 · 每個「提供規格」儲存格均為空。切換到之後 →

案例 · 經絡健康

十一家醫院，
一個採購委員會。

“每個缺口在匯入時就浮出水面。我們在委員會看到文件之前就知道哪個投標人是合規的。”

— 採購主管，經絡健康網絡

6週變3天

響應時間 280 行招標書

$210萬

收回金額匯入時發現的投標

Procurement teams and bidders using MedStrato

Meridian Health

Apex Medical

Stratus Gov

Ovum Diagnostics

Polaris Tender Bureau

NordClinic

運作原理

從原始招標書
到可提交文件，四步完成。

上傳混亂的表格。拿回一份委員會可以簽字的文件。

01 / 匯入

上傳任意表格。

XLSX、CSV、PDF。多標籤頁、合併儲存格、任意格式。

R11_Ultrasound_Doppler_Tech.xlsx

Ultrasound

Anesthesia

Lab

+37

Parsing sheet 1 of 40

2,840 cells detected

02 / 映射

欄位自動映射。

開箱識別 40+ 種表格格式。

req_no

→

Requirement

spec_r

→

Required Spec

spec_o

→

Offered Spec

comp_%

→

Compliance

notes

→

Notes

03 / 匹配

匹配產品資料。

索引產品目錄、備案文件、認證材料。

01Frequency range92%

02Doppler modes98%

03Screen size74%

04Battery backup—

05I/O ports100%

04 / 審查

即時發現缺口。

合規率、部分匹配、缺失項——提交前盡知。

Match0
Partial0
Gap0

Export compliance letter

平台

四大引擎。
一個工作流。

專為醫療器械招標打造。不是改裝的 RFP 工具。

01 · 自動匹配

162 行，不到一分鐘。

語義匹配。返回匹配 / 部分匹配 / 缺口及置信度。

Auto Match · ● running

Rows scanned0/162

Avg. confidence0%

Match0

Partial0

Gap0

02 · 合規

默認審計就緒。

每次匹配的證據鏈。產品目錄、資料表、備案文件。

Row 07 · Evidence chain

📄

Datasheet

EP500 · p4 §2.3

🏛

FDA 510(k)

K193821

✓

Attestation

Signed 2025-09-14

⬡

Catalog

Indexed 2026-01-04

03 · 法規

FDA · CE · NIE 已驗證。

匯入時交叉校驗。召回和危險內聯顯示。

Regulatory status · checking…

FDA510(k) K193821Clear

CEMDR 2017/745Clear

NIEHSA-MD-2024Review

MHRAUKCA pendingAlert

04 · 情報

情報，有上下文。

中標率、定價、競爭對手報價——基於匹配的 SKU。

Unit pricing · EP500 · −3.2% vs median

You$12,840−$420

Median$13,260baseline

Competitor A$14,100+$840

New · AI Agent

Meet Orbid.
The agent that runs the bid.

Orbid is an autonomous AI agent that processes medical device tenders end to end. It handles the mechanical work so your team focuses on strategy and review.

Read

Parses the full tender document

Match

Maps your catalog to every line item

Comply

Checks specs against 14 regulatory regimes

Draft

Produces a submission-ready response

See how Orbid works →

平台

七大模組。
一個招標生命週期。

從機會發現到得標後合規——每個階段都有專屬介面。

01 / 招標前

提前發現。

在機會公開前找到它們。投標前瞭解規則。

機會

+86 新

全球每一個公開的醫療器械招標。根據你的產品目錄篩選，評分匹配度，截止日前提醒。

38 個國家12k 資料源匹配度評分

政策

按司法管轄區劃分的法規、關稅和採購規則。任何變更均有差異對比。

FDA · CE · NIE變更日誌按司法管轄區

02 / 執行

贏得標書。

核心工作流。匹配規格，拉取證據，引入合適的專家。

標書

核心

規格匹配器、合規網格、證據鏈。上方的即時演示。

162 行 / 46秒0.3% 誤報

產品

橫跨 2,800 家製造商的 140 萬索引 SKU。你的目錄、他們的目錄，交叉引用。

140萬 SKU資料表定價

專家

臨床和法規審查專家網絡。對部分匹配和缺口請求第二意見。

按需已驗證

03 / 得標後

保住得標。

在交付、召回和續約過程中保持合同合規。

活動

追蹤每個活躍獎項。里程碑、義務、續約窗口——在一個時間線上。

里程碑續約SLA

法規

召回資訊、MDR/IVDR 截止日期、審計日誌——對應到其影響的獎項。

召回MDR/IVDR審計日誌

你的下一個標書
週五截止。

三十分鐘。五十個行項目，即時匹配，對照你的真實標書。

申請存取聯繫創辦人

將醫療器械招標變成 可提交的 文件。

十一家醫院，一個採購委員會。

從原始招標書到可提交文件， 四步完成。

上傳任意表格。

欄位自動映射。

匹配產品資料。

即時發現缺口。

四大引擎。 一個工作流。

162 行，不到一分鐘。

默認審計就緒。

FDA · CE · NIE 已驗證。

情報，有上下文。

Meet Orbid.The agent that runs the bid.

七大模組。 一個招標生命週期。

提前發現。

贏得標書。

保住得標。

你的下一個標書週五截止。

將醫療器械招標
變成可提交的文件。

十一家醫院，
一個採購委員會。

從原始招標書
到可提交文件，四步完成。

四大引擎。
一個工作流。

Meet Orbid.
The agent that runs the bid.

七大模組。
一個招標生命週期。

你的下一個標書
週五截止。