RC

RadUnity Corp.

Regulatory Consulting Firm

RadUnity Corp. is a distinguished FDA regulatory consulting firm with over a decade of proven expertise, dedicated to accelerating the market entry of innovative medical devices. Their seasoned team specializes in navigating the intricate FDA regulatory landscape, with a particular focus on radiology, oncology, and imaging devices, including SaMD. They excel in guiding clients through complex path...

Experience: 11+ years

Submissions: 15 510(k), 3 De Novo, 1 PMA

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

RadiologyIvd

Regions Served

RadUnity Corp. provides regulatory consulting services to clients in:

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

Credentials & Recognition

Certifications

Regulatory Affairs Certified - United States
RAPS
2015

Professional Experience

Former FDA Regulatory Specialist
Verified FDA experience

Executive Summary

Professional Overview

RadUnity Corp. is a distinguished FDA regulatory consulting firm with over a decade of proven expertise, dedicated to accelerating the market entry of innovative medical devices. Their seasoned team specializes in navigating the intricate FDA regulatory landscape, with a particular focus on radiolog...

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdeQ Sub

Device Specialties

RadiologyIvd

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
  • Background: 11+ years of regulatory experience.

Cruxi view

RadUnity Corp. distinguishes itself as a leading FDA regulatory consulting firm with over a decade of specialized experience, particularly adept at accelerating market entry for innovative medical devices. Their seasoned team possesses deep expertise in navigating intricate regulatory pathways like 510(k) submissions (15 successful), De Novo requests (3 handled), and PMA applications (1 handled), with a notable focus on radiology, oncology, and imaging devices, including SaMD. The firm's comprehensive service suite, covering everything from initial strategy and robust QMS implementation to post-market surveillance, coupled with their demonstrated success in Class II and Class III devices, makes them an invaluable strategic partner. Medtech companies will find RadUnity Corp.'s extensive track record and commitment to efficient and effective regulatory success particularly compelling.

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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