Dedicated FDA Guidance for Your MedTech Journey
In today’s stringent regulatory environment, success demands deep FDA expertise, strategic foresight, and exceptional flexibility. Our team brings decades of experience across all CDRH divisions, providing an insider perspective that transforms compliance challenges into opportunities for your medical technology’s advancement.
Regulatory Strategy and Intelligence
We develop comprehensive regulatory strategies that align with your commercial objectives, establishing clear pathways while anticipating potential challenges unique to your MedTech innovation.
- Strategic assessment of regulatory requirements—global vs. local
- Submission type determination and pathway optimization
- Data requirements analysis and evidence generation planning
- Quality system requirements assessment
- Timeline development with critical milestone identification
- Competitive landscape analysis and strategic positioning
Device Classification and Conformity Assessments
Our regulatory consulting team works to secure the most efficient pathway to market, leveraging a deep understanding of FDA precedent while remaining agile enough to pivot if classification challenges arise.
- Intended use/indications for use statement development
- Predicate device identification and substantial equivalence positioning
- Device coding and categorization alignment
- Conformity assessments and requirements mapping
- Benefit-risk profile development for regulatory positioning
Regulatory Submission Preparation
We craft meticulously prepared regulatory submissions that anticipate reviewer questions and present your medical technology’s benefits and distinctive competencies in the most favorable light for FDA consideration.
- FDA Premarket Submissions
- Pre-submissions (Q-Sub) strategy and development
- Study risk determinations (SRD)
- Investigational device exemptions (IDE)
- Breakthrough device designations (BDD)
- Emergency use authorizations (EUAs)
- Humanitarian use device (HUD)/Humanitarian device exemption (HDE)
- Premarket notification (510(k))
- De Novo classification requests
- Premarket approval applications (PMA)
- Comprehensive technical documentation preparation
- FDA-specific presentations of data
Agency Interaction and Negotiation
We orchestrate strategic FDA communications that secure valuable feedback while effectively advocating for your medical technology throughout the pre-submission and review processes. Along the way, we adapt our approach based on agency feedback to maintain momentum.
- Strategic FDA meeting preparation and representation
- Deficiency letter response development and negotiation
- Advisory panel preparation and presentation support
- Regulatory agency liaison – meeting facilitation
- Agile response planning for evolving FDA questions and concerns
- Post-submission follow-up and review management
Quality System Support and Inspection Readiness
Our comprehensive quality system approach ensures FDA compliance throughout your MedTech product lifecycle while preparing your organization for successful regulatory inspections.
- Quality system implementation aligned with FDA QMSR requirements
- Mock inspections and audit preparation
- Quality system audit execution (FDA QMSR, ISO 13485, etc.)
- Inspection and audit readiness (FDA, Notified Body, etc.)
- Standard operating procedure development and review
- Personnel training on FDA requirements and inspections
- Due diligence assessments ahead of acquisitions
- Remediation strategy development and implementation
Post-Market Support and Lifecycle Management
Our approach extends beyond initial approval to maximize your MedTech product’s commercial potential through label expansions, post-approval modifications, and efficient post-market regulatory compliance.
- Post-approval change assessment and implementation planning
- Gap assessment and change control
- Regulatory intelligence—changing regulatory requirements
- Impact/gap assessment and transition strategies
- Remediation recommendations
- Decision tree analysis support
- Annual reporting and regulatory maintenance management
- Recall and field action management with FDA coordination
- Post-market surveillance system implementation
- Next-generation product transition strategies
Our Clients Recognize the Beaufort Difference
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Beaufort’s ability to grasp and articulate the clinical medical value in the field of in vitro diagnostics enabled our company to strategically align our FDA trials and submissions to meet the ever-increasing standards of the FDA.
Your MedTech Regulatory Edge
Expert FDA guidance tailored to MedTech. Beaufort’s regulatory team helps you accelerate approvals with strategic insight, pathway clarity, and proven experience.
Agency Insight
Our team includes former FDA reviewers who provide invaluable perspective on how submissions are evaluated, enabling us to craft applications precisely tailored to agency expectations and reviewer concerns.
Strategic Positioning
We transform regulatory requirements from obstacles to strategic opportunities, positioning your technology for optimal classification and expedited pathways that competitors often miss.
Submission Precision
Our comprehensive FDA submission approach ensures perfect alignment between your medical technology’s unique value proposition and specific regulatory requirements, dramatically reducing deficiency letters and review cycles.
Lifecycle Perspective
Unlike narrowly focused approaches, our comprehensive strategy considers your entire product lifecycle, from initial classification through post-market modifications, ensuring long-term regulatory sustainability.
News & Insights
Access our expert insights across a breadth of clinical challenges—
from evolving global regulations to the latest practice guidelines—that
are shaping tomorrow’s MedTech landscape.
