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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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Verified Heritage:
Abbott Cook Medical Baxter
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