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Classification, Labeling, and FDA Pathways: Getting the Device Right Before It Ships Beacon RS LLC 0
快速进入美国市场:10 分钟内选择正确的起点 Beacon RS LLC 0
进口准备与上市后义务:在产品发布后保持持续合规 Beacon RS LLC 0
分类、标签与 FDA 途径:确保器械在发货前符合规范 Beacon RS LLC 0
从注册到治理:保持您的 FDA 产品组合整洁有序 Beacon RS LLC 0
Entering the U.S. Medical Device Market: A Practical Regulatory Onboarding Playbook Beacon RS LLC 0
进入美国医疗器械市场:实用的 FDA 入驻指南 Beacon RS LLC 0

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Beacon Regulatory Services LLC

Beacon Regulatory Services (BRS) LLC acts as the decisive U.S. regulatory interface for medical device manufacturers worldwide.

We replace administrative uncertainty with audit-ready precision—managing FDA Establishment Registrations, Device Listings, and U.S. Agent obligations.

Headquarters
9105 E 56th St, Ste J #2057
Indianapolis, IN 46216, USA
Direct Line
+1 (317) 662-0910
Regulatory Inquiries
info@beaconfda.com
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Engagement Process
Streamlined Onboarding
1
Submit Scope
Share device type & goals via secure intake.
2
Analysis & Proposal
We confirm regulatory pathway & costs.
3
Execution
Immediate filing & U.S. Agent appointment.
Response Target: 1 Day
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Abbott Cook Medical Baxter
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