Frequently Asked Questions (FAQs)
This FAQ is a starting point for the whole site. Each answer provides a short response and a “learn more” link so you can quickly navigate to the most relevant page for your situation.
Top 10 questions BRS LLC is asked
1. What does Beacon Regulatory Services (BRS LLC) actually do?
BRS LLC is a founder-led, boutique FDA consulting firm focused on medical devices. We act as your U.S. regulatory interface, covering U.S. Agent responsibilities, FDA Establishment Registration, Device Listings, portfolio clean-up, and senior regulatory advisory support.
Learn more: About Us, Services overview, Who we help.
2. How do we start an engagement with BRS LLC?
The best starting point is to share your company, device type, and U.S. plans via the contact intake form. We then confirm scope, timelines, and next steps, and move into a structured onboarding flow when both sides agree to proceed.
Learn more: Start here: engagement steps, Contact & intake form.
3. Do you only handle U.S. Agent, establishment registration, and device listing?
No. Those are core anchors, but we also support device listing portfolio clean-up, regulatory advisory for leadership teams, and adjacent quality / audit-readiness topics where FDA registrations and listings intersect with your broader QMS.
Learn more: U.S. Agent & FDA Device Listing, Establishment Registration, Portfolio Clean-Up, Regulatory Advisory.
4. What types of companies does BRS LLC typically work with?
We work with non-U.S. manufacturers entering the U.S., U.S. SMEs cleaning up legacy portfolios, distributors representing foreign OEMs, and investors / early-stage teams needing realistic FDA roadmaps for due diligence or fundraising.
Learn more: Who we help, Services, Investors.
5. Are you an importer of record or distributor?
No. BRS LLC acts as a regulatory U.S. Agent and FDA interface. We do not act as importer of record, distributor, or commercial representative. We focus on keeping your FDA registrations, listings, and regulatory interactions clean and defensible.
Learn more: U.S. Agent & Device Listing, Contact & intake form.
6. How does pricing work for your services?
Pricing is driven by scope and complexity: number of sites, devices, and listings; whether we are handling initial registration, portfolio clean-up, or ongoing maintenance. We provide transparent estimates and typically structure work as defined projects with optional follow-on support.
Learn more: Start here: engagement steps, Services overview, Request a consult.
7. How do you handle data privacy, PHI, and confidentiality?
We intentionally keep PHI and patient identifiers out of web forms and email links. Formal engagements are supported with appropriate confidentiality terms and structured document exchange. Our aim is to protect your information while meeting FDA and data protection expectations.
Learn more: Privacy Policy, Security Statement, Engagement & data handling.
8. Where can I find your legal and compliance statements?
All legal notices, terms of use, cookie and privacy information, and disclaimers are centralized in the Legal & Privacy hub. These pages explain how the site is intended to be used and what BRS LLC does—and does not—provide.
Learn more: Legal & Privacy hub, Terms of Use, Disclaimer.
9. How can press or media contact BRS LLC?
Media, conferences, and professional associations can route enquiries through the Media Center or by emailing the main information mailbox. From there, we triage to the appropriate contact and agree the right level of response.
Learn more: Media Center,
10. I’m interested in careers or partnering with BRS LLC. Where should I go?
BRS LLC is a remote-first, founder-led boutique. We occasionally open roles and are always interested in hearing from experienced regulatory, quality, and client-service professionals, as well as potential partners and investors.
Learn more: Careers, Investors, Contact & intake.