Regulatory Advisory & Project Support

Core Service

Regulatory Advisory & Project Support for Medical Devices

Senior FDA medical device judgment and structured workplans—without the compliance debt.

Not every regulatory challenge is a “form submission.” Many are cross-functional execution problems. BRS LLC provides regulatory advisory as a practical extension of your team—bringing structured workplans and decision-ready outputs so you can move forward confidently.

Designed for RA/QA leaders, founders, and deal teams facing time-sensitive FDA device decisions.

Regulatory Advisory
Concepts Assessment RACI Pricing FAQs Request Consult
Core Concepts
Regulatory Advisory

Structured interpretation and decision support grounded in applicable FDA medical device requirements and practical enforcement realities—so you can choose a path that is both compliant and executable.

Project Support

Short-cycle execution help—workplans, evidence organization, stakeholder alignment, and documentation packages that reduce ambiguity and accelerate delivery of your device strategy.

Who Needs This?

  • • Foreign manufacturers needing clear U.S. regulatory direction.
  • • Startups and growth-stage companies preparing for scale.
  • • Teams managing transitions (acquisitions, new sites).

What We Deliver

  • • Regulatory pathway assessments and implications, with recommended options and risk trade-offs.
  • • Evidence and documentation readiness packages that can drop directly into submissions or QMS records.
  • • Risk-based prioritization frameworks aligned with commercial milestones such as launch, funding, or acquisitions.

Typical Execution

  • ✓ Labeling & claims reviews
  • ✓ Import readiness checks
  • ✓ Change impact assessments
  • ✓ Distributor onboarding
  • ✓ Board- or investor-ready regulatory summaries for key decisions.

Roles & Responsibilities (RACI)

Clear accountability for every step of the process.

AreaYour TeamBRS LLC
Objectives Confirm business goals, timelines, and constraints. Translate into workplan, owners, and decision checkpoints.
Inputs Provide product, labeling, and evidence inputs. Assess gaps, create decision-ready outputs, and document rationale.
Execution Approve key decisions and provide stakeholder access. Run cadence, deliverables, and escalation management.
Sustainability Adopt governance internally using agreed triggers and owners. Provide templates, change triggers, and prioritization to support long-term adoption.

Pricing & Coverage Options

Advisory work is scoped for speed and clarity. Choose a Sprint, Retainer, or Project structure tailored to your FDA medical device needs.

Sprint

Fast clarity for specific hurdles.

Fixed / Scope
  • ✓ Pathway decision + rationale
  • ✓ Gap assessment
  • ✓ Action plan + owners
  • ✓ Decision-ready outputs

Example: 510(k) vs. de novo pathway decision with impact on timeline and evidence.

Request Proposal

Retainer

Ongoing decision support & triage.

Monthly / Access
  • ✓ Most Popular choice
  • ✓ Monthly advisory cadence
  • ✓ Priority triage
  • ✓ Templates + governance

Example: ongoing labeling and claims review, change impact assessments, and import readiness across a growing device portfolio.

Inquire for Rates

Project

Defined deliverables & execution.

Custom / Outcome
  • ✓ Defined scope + timeline
  • ✓ Cross-functional coordination
  • ✓ Evidence package build
  • ✓ Implementation support

Example: remediation plan and execution support following a 483, internal audit, or portfolio gap assessment.

Request Proposal

Need decision-ready support?

Get clarity that you can operationalize immediately.

Request a Consult

Frequently Asked Questions

What types of questions fit advisory support?
Pathway decisions, classification thinking, labeling/claims alignment, change impact assessments, readiness planning, and prioritization when timelines are tight.
Do you provide “decision-ready” outputs?
Yes. Typical deliverables include rationales, scoped workplans, prioritization frameworks, and partner-ready summaries that you can operationalize immediately.
How quickly can you start?
Most Sprints can be scoped within a week and initiated within 5–10 business days, depending on complexity and availability of inputs.
Why choose BRS LLC for advisory and project support?
Senior FDA medical device judgment plus disciplined execution—so deliverables are not only compliant, but actionable, board-ready, and sustainable.
Can you support short, urgent projects?
Yes—Sprint coverage is designed for fast clarity with a controlled scope and defined deliverables.
Will you run the project cadence for us?
We can—lightweight project management with owners, timelines, evidence tracking, and decision checkpoints.
How do you keep the work from getting too academic?
We bias toward execution: what to do next, what evidence is needed, and how to document decisions so they stand up to scrutiny.
Can advisory integrate with U.S. Agent and listings work?
Yes—advisory can sit on top of execution to keep decisions aligned with operational reality and administrative compliance.
Do you provide templates or playbooks?
When appropriate—especially for governance, change triggers, evidence organization, and audit readiness.
How do you scope the engagement?
We start with the outcome you need, then define the minimum viable scope to deliver it—keeping cost and timelines predictable.