Veranex
ListedFull-Service CRO | FDA 510(k) & PMA Expert | Medtech Design, Regulatory & Commercialization
eSTARPredicate researchRTA remediationLabeling reviewProject management
AI/ML Medical Device Consultants
Find experienced regulatory consultants specializing in AI/ML medical devices, including machine learning diagnostics, AI-powered imaging, and adaptive algorithms.
15 shown
116 total providers in marketplace
Directory: FDA 510(k) Submission Services
MCRA
ListedMCRA – Expert FDA Regulatory Consulting for Medical Devices
Predicate researchProject management
Freyr Solutions
ListedFreyr Solutions – Expert FDA Regulatory Consulting for Medical Devices
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Jose Ayala
ListedGlobal Quality & Regulatory Executive | 41 Yrs MedTech | FDA, EU MDR, ISO | 130+ Class II/III Approvals |...
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FDAMap
ListedExpert Regulatory Services for Drugs, Biologics, and Devices
Project management
de novo jury consulting
Listedde novo jury consulting: Expert FDA Regulatory Strategy for De Novo, 510(k), and PMA Submissions
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Biologics Consulting Group
ListedExpert FDA Regulatory Guidance for Medtech - 510k, De Novo, PMA & More
Project management
RadUnity Corp.
ListedRadUnity Corp.: Expert FDA Regulatory Guidance for Medical Device Innovators | 11+ Years Experience
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DEMET (DEE) GRACE SAG, PhD
ListedTranslational Medicine & Regulatory Affairs Executive | 15+ Years | Drugs, Biologics, Devices, IVDs
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Leavitt Partners
ListedLeavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation
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OMID SOURESRAFIL
Claimed25+ Yrs MedTech Leader: Regulatory, Clinical, Product Dev, AI, SaMD, Cybersecurity. Global Approvals.
Predicate researchRTA remediation
Shahid Siddiqui, Ph.D.
ClaimedExpert in Drug Discovery, Medical Devices (IVDR), and Regulatory Affairs with 15+ years experience
Predicate researchRTA remediation
Sunita Teekasingh
ClaimedRegulatory Affairs Strategy Director | 15+ Yrs Global Medtech & IVD Compliance | FDA Clearances & Crisis Management
eSTARPredicate researchRTA remediationLabeling reviewProject management
Raje Devanathan
ClaimedCertified QA/RA Leader | 22+ Yrs Life Sciences | QMS, MDSAP, FDA, EU MDR | eQMS & Digital Compliance Expert
eSTARPredicate researchRTA remediationLabeling reviewProject management
Amey Kawale
ClaimedExpert QMS & ISO 14971 Risk Management Pro | EU MDR, SaMD, IVD Compliance | 10+ Yrs MedTech Experience
RTA remediation