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The FDA Group

Leading FDA Regulatory Consulting Firm

The FDA Group is a premier FDA regulatory consulting firm dedicated to empowering medical device companies. With seasoned experts, they specialize in strategic planning and execution for 510(k) submissions, de novo applications, and PMA processes across various device classes and panels. They provide tailored solutions accelerating product development and ensuring compliance through comprehensive ...

Experience: 7+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

OphthalmicGeneral SurgeryIvdRadiologyDental

Regions Served

The FDA Group provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Executive Summary

Professional Overview

The FDA Group is a premier FDA regulatory consulting firm dedicated to empowering medical device companies. With seasoned experts, they specialize in strategic planning and execution for 510(k) submissions, de novo applications, and PMA processes across various device classes and panels. They provid...

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

OphthalmicGeneral SurgeryIvdRadiologyDental

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

  • Regions: US, EU
  • Background: 7+ years of regulatory experience.

Cruxi view

The FDA Group stands out as a premier FDA regulatory consulting firm with a robust team of seasoned experts, offering unparalleled depth in navigating complex medical device regulatory pathways. Their comprehensive expertise spans 510(k) submissions (traditional and special), de novo applications, and PMA processes across all device classes (I, II, and III) and a broad spectrum of device panels including ophthalmic, cardiovascular, and neurology. The firm demonstrates a strong technical competency with explicit services for Software as a Medical Device (SaMD), AI/ML, implantables, and IVD tests, further supported by their proficiency in Quality Management Systems (QMS) and international regulatory strategies for US and EU markets. With a clear commitment to accelerating product development and ensuring compliance, The FDA Group's extensive service offering, from initial pathway assessment and predicate analysis to full submission authoring and post-market vigilance, positions them as an indispensable strategic partner for medtech companies of all sizes, from startups to large enterprises.

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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