What services does FDAMap offer?

FDAMap offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does FDAMap specialize in?

FDAMap specializes in 510k, De Novo, Pma and other FDA regulatory pathways for medical devices.

What is FDAMap's regulatory experience?

FDAMap has 10+ years of experience, 35+ 510(k) submissions in FDA regulatory affairs.

FDAMap

Regulatory Consulting Firm

FDAMap provides expert regulatory services across drugs, biologics, and devices, offering comprehensive support for navigating the complex FDA landscape. With a decade of experience, they specialize in strategic regulatory planning, risk management, and quality system implementation, ensuring compliance and facilitating market access for a wide range of medical products.

Experience: 10+ years

Submissions: 35 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaPre-SubmissionBreakthrough Devices

Device Specialties

General SurgeryGastroenterologyUrologyCardiovascularOrthopedic

Regions Served

FDAMap provides regulatory consulting services to clients in:

United States (FDA)

Credentials & Recognition

Certifications

RAC-US
2025

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaPre-SubmissionBreakthrough Devices

Device Specialties

General SurgeryGastroenterologyUrologyCardiovascularOrthopedic

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

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
Background: 10+ years of regulatory experience.

Cruxi view

Experience with De Novo submissions for novel devices. Global regulatory expertise across multiple markets. Regulatory services across drugs, biologics, and devices

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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