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FDA Compliance Group LLC

Regulatory Consulting Firm

FDA Compliance Group LLC is a premier FDA regulatory consulting firm comprised of former FDA employees dedicated to guiding medical device, drug, dietary supplement, and food companies through the intricate landscape of FDA regulations. Our seasoned team leverages extensive firsthand experience within the FDA to provide strategic regulatory pathways, robust submission authoring, comprehensive qual...

Experience: 7+ years

Submissions: 15 510(k), 5 De Novo, 3 PMA

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaQ SubPost Market

Device Specialties

CardiovascularNeurologyOrthopedicGeneral SurgeryGastro Urology

Regions Served

FDA Compliance Group LLC provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-Pacific

Credentials & Recognition

Professional Experience

Former FDA Regulatory Specialist
Verified FDA experience

Executive Summary

Professional Overview

FDA Compliance Group LLC is a premier FDA regulatory consulting firm comprised of former FDA employees dedicated to guiding medical device, drug, dietary supplement, and food companies through the intricate landscape of FDA regulations. Our seasoned team leverages extensive firsthand experience with...

Core Specializations

Regulatory Pathways

510kDe NovoPmaQ SubPost Market

Device Specialties

CardiovascularNeurologyOrthopedicGeneral SurgeryGastro Urology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Former roles: Former FDA regulatory specialist.
  • Regions: US, EU, CA, APAC
  • Background: 7+ years of regulatory experience.

Cruxi view

FDA Compliance Group LLC distinguishes itself as a premier FDA regulatory consultancy for medtech companies, boasting a formidable team of former FDA employees. This unique composition allows them to offer unparalleled, firsthand insights into FDA's internal workings, translating into highly effective regulatory strategies and submissions for complex pathways such as 510(k)s, De Novos, and PMAs. Their deep expertise spans Class II and Class III devices across numerous panels, including cardiovascular, neurology, and IVD, and extends to cutting-edge technologies like SaMD and AI/ML. With a proven track record, demonstrated by handling 15 510(k)s, 5 De Novos, and 3 PMAs, the firm is exceptionally equipped to guide medtech innovators through critical regulatory processes, ensuring timely market access and sustained compliance.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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