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EAS Consulting Group

EAS Consulting Group is a dedicated FDA regulatory consulting firm with 15 years of experience, specializing in supporting medical device companies. They offer comprehensive services including 510(k) submission authoring, regulatory pathway assessment, ISO 13485 Quality Management System consulting, FDA mock audits, inspection readiness, and ISO 14971 risk management.

Experience: 15+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPre-SubmissionIdeDe NovoBreakthrough Devices

Device Specialties

General SurgeryGastro UrologyOrthopedicNeurologyCardiovascular

Executive Summary

Professional Overview

EAS Consulting Group is a dedicated FDA regulatory consulting firm with 15 years of experience, specializing in supporting medical device companies. They offer comprehensive services including 510(k) submission authoring, regulatory pathway assessment, ISO 13485 Quality Management System consulting,...

Core Specializations

Regulatory Pathways

510kPre-SubmissionIdeDe NovoBreakthrough Devices

Device Specialties

General SurgeryGastro UrologyOrthopedicNeurologyCardiovascular

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

  • Background: 15+ years of regulatory experience.

Cruxi view

EAS Consulting Group is a regulatory compliance solution provider specializing in FDA and USDA regulated industries. They offer consulting, submissions, auditing, training, and legal support services.

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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