RadUnity Corp.
RadUnity Corp.: Expert FDA Regulatory Guidance for Medical Device Innovators | 11+ Years Experience
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 pathways such as 510(k) submissions, De Novo requests, PMA applications, and Investigational Device Exemptions (IDE). Their comprehensive service suite ensures efficient and effective regulatory success, from initial strategy development and robust Quality Management System (QMS) implementation to ongoing post-market surveillance. RadUnity Corp. is committed to being your strategic partner in bringing groundbreaking medical technologies to patients swiftly and compliantly, offering deep insights into Class II and Class III devices.
About
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 pathways such as 510(k) submissions, De Novo requests, PMA applications, and Investigational Device Exemptions (IDE). Their comprehensive service suite ensures efficient and effective regulatory success, from initial strategy development and robust Quality Management System (QMS) implementation to ongoing post-market surveillance. RadUnity Corp. is committed to being your strategic partner in bringing groundbreaking medical technologies to patients swiftly and compliantly, offering deep insights into Class II and Class III devices.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** RadUnity Corp.
- **Years of experience:** 11
- **510(k)s submitted (self-reported):** 15
- **Ex-FDA:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme
- **Location:** GB
- **Availability:** available_now
- **Certifications:** Regulatory Affairs Certified - United States
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** RadUnity Corp. uniquely offers a decade of focused FDA regulatory expertise, demonstrated by a strong track record in key submission types, specifically for radiology and oncology devices. Their comprehensive service offering, from initial strategy to post-market surveillance, combined with a deep understanding of Class II and Class III devices, positions them as a critical partner for accelerating time-to-market for medtech innovators.
- **Ideal projects:** The ideal medtech client for RadUnity Corp. is a startup or SME developing innovative radiology, oncology, or imaging devices, especially those involving Software as a Medical Device (SaMD). This firm excels with projects requiring guidance through complex 510(k) submissions, De Novo requests, or PMA applications, and those seeking robust Quality Management System (QMS) setup and ongoing post-market support. Medtech companies should engage RadUnity Corp. when they require a strategic partner to efficiently and compliantly navigate the FDA regulatory landscape, aiming to bring groundbreaking technologies to market swiftly, particularly for Class II and Class III devices.
- **Confidence score:** 95/100
- **Last analyzed:** Sat Dec 20 2025 01:42:14 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international, de_novo
- **Device classes:** class-ii, class-iii
- **Specialties:** radiology, software-samd, regulatory strategy, quality management systems
- **Device panels:** radiology, ivd
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
- **Type:** firm
- **Company:** RadUnity Corp.
- **Years of experience:** 11
- **510(k)s submitted (self-reported):** 15
- **Ex-FDA:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme
- **Location:** GB
- **Availability:** available_now
- **Certifications:** Regulatory Affairs Certified - United States
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** RadUnity Corp. uniquely offers a decade of focused FDA regulatory expertise, demonstrated by a strong track record in key submission types, specifically for radiology and oncology devices. Their comprehensive service offering, from initial strategy to post-market surveillance, combined with a deep understanding of Class II and Class III devices, positions them as a critical partner for accelerating time-to-market for medtech innovators.
- **Ideal projects:** The ideal medtech client for RadUnity Corp. is a startup or SME developing innovative radiology, oncology, or imaging devices, especially those involving Software as a Medical Device (SaMD). This firm excels with projects requiring guidance through complex 510(k) submissions, De Novo requests, or PMA applications, and those seeking robust Quality Management System (QMS) setup and ongoing post-market support. Medtech companies should engage RadUnity Corp. when they require a strategic partner to efficiently and compliantly navigate the FDA regulatory landscape, aiming to bring groundbreaking technologies to market swiftly, particularly for Class II and Class III devices.
- **Confidence score:** 95/100
- **Last analyzed:** Sat Dec 20 2025 01:42:14 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, qms, international, de_novo
- **Device classes:** class-ii, class-iii
- **Specialties:** radiology, software-samd, regulatory strategy, quality management systems
- **Device panels:** radiology, ivd
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
Key Highlights
- 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 compre
- RadUnity Corp. uniquely offers a decade of focused FDA regulatory expertise, demonstrated by a strong track record in key submission types, specifically for radiology and oncology devices. Their comprehensive service offering, from initial strategy to post-market surveillance, combined with a deep understanding of Class II and Class III devices, positions them as a critical partner for accelerating time-to-market for medtech innovators.
Certifications & Trust Signals
- 11 years experience
- 15 510(k)s submitted (self-reported)
- Ex-FDA
Buyer Snapshot
Best for
- The ideal medtech client for RadUnity Corp. is a startup or SME developing innovative radiology, oncology, or imaging devices, especially those involving Software as a Medical Device (SaMD). This firm excels with projects requiring guidance through complex 510(k) submissions, De Novo requests, or PMA applications, and those seeking robust Quality Management System (QMS) setup and ongoing post-mark
HQ:
Madison, GB
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
11
Num510k Submitted:
15
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
radiology, ivd
Technology Types:
Photon Counting Detector (PCD) CT, CT scanner technologies, dual energy/spectral CT, AI driven Xray and CT Imaging, CT Imaging Physics, CT reconstruction, AI in CT Image enhancement & Image analysis, large language models in radiology
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Engagement Models:
Research Collaboration, Show Site Hosting, Guidance
