Full 510(k) Authoring Consultants

Pure Global offers AI-powered regulatory consulting and local representation for medical device market access in over 30 markets. Accelerate your entry with their flat-fee services.

Full-Service CRO | FDA 510(k) & PMA Expert | Medtech Design, Regulatory & Commercialization

RQM+: FDA Regulatory Consulting for MedTech & Software Expertise

FDA 510(k), De Novo, PMA Consulting for Medical Devices by Emergo by UL

MCRA – Expert FDA Regulatory Consulting for Medical Devices

de novo jury consulting: Expert FDA Regulatory Strategy for De Novo, 510(k), and PMA Submissions

Lachman Consultants: Expert FDA Regulatory Consulting for Medical Devices

NAMSA: FDA 510(k) Regulatory Consulting Expert | 15 Years Experience | Global Support

Expert FDA 510(k) Regulatory Consulting | Biomedical Engineering Expertise | 12 Years Experience

Expert FDA 510(k) Regulatory Consulting for Medical Devices

Fang Consulting – FDA Regulatory & QMS Expert for Medical Devices

ALKU – Expert FDA 510(k) & Regulatory Consulting for Medical Devices

Elexes – Expert FDA 510(k) & Regulatory Consulting for Medical Devices

Expert FDA 510(k) Regulatory Consulting Firm | Global Testing & Training

Freyr Solutions – Expert FDA Regulatory Consulting for Medical Devices

FDA 510(k) Regulatory Consulting Firm

Regulatory Affairs Strategy Director | 15+ Yrs Global Medtech & IVD Compliance | FDA Clearances & Crisis Management

Expert Regulatory Services for Drugs, Biologics, and Devices

Axeon LLC – FDA 510(k) & Regulatory Consulting | 20 Years Experience

PCG – U.S. FDA Regulatory Consulting for Medical Devices

Leavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation

Regulatory Compliance Associates – FDA Regulatory Consulting for Medical Devices

Biologics Consulting – Expert FDA 510(k) & Regulatory Consulting

Expert FDA Regulatory Guidance for Medtech - 510k, De Novo, PMA & More

Qualio – FDA 510(k) & Regulatory Consulting Expertise

FDA 510(k) Third Party Review Organization | Expert Regulatory Consulting | Class I & II Devices

FDA 510(k) Regulatory Consulting & Global Intelligence Platform for Medical Devices

FDA 510(k) Regulatory and Quality Consulting Firm - 12 Years Experience

FDA 510(k) & QMS Consulting for Class I/II Medical Devices | 12 Years Experience

FDA 510(k) Regulatory Consulting | Biostatistics & Testing Planning for Medical Devices

Expert QA/RA Director | MedTech Product Launch | FDA, EU-MDR, MDSAP | QMS & Validation Specialist

Seasoned Global Quality & Regulatory Executive | Medical Devices | FDA Submissions, QMS & EU MDR Expert

Expert FDA Regulatory Consulting for Medtech: 510k, De Novo, PMA

i3cglobal: Expert FDA 510(k) & Regulatory Strategy Consulting for Medical Devices

RadUnity Corp.: Expert FDA Regulatory Guidance for Medical Device Innovators | 11+ Years Experience

Lexology – FDA 510(k) & Regulatory Consulting

J&J – FDA 510(k) & Regulatory Consulting for Medical Devices

Regulatory Affairs Professional | 4+ Yrs Exp | 510(k), De Novo, Clinical Trials | Biologics & Medical Devices

FDA 510(k) Regulatory Consulting Firm | QMS | Class I & II Devices

FDA 510(k) & De Novo Consulting for Medical Device Startups | DocLab Inc.

FDA 510(k) Consulting for SaMD & Digital Health Devices | 12 Years Experience | US & EU Client Focus

Expert FDA 510(k) Regulatory Consultant specializing in Ultrasound and Implant Devices | 20 Years Experience

FDA 510(k) Regulatory Consulting Services

Regulatory Affairs Expert with 2+ Years of MedTech Experience - Enhancing Compliance for Medical Devices

Senior FDA Regulatory & IVD Consultant | 30+ Years Experience | 510(k), De Novo, EUA Expert | Inventor of...

MedTech Regulatory & Project Leader | Combination Products | 510(k) & EU MDR | QMS & Validation Expert

Global Quality & Regulatory Executive | 41 Yrs MedTech | FDA, EU MDR, ISO | 130+ Class II/III Approvals |...

Regulatory Compliance Associates (RCA) – FDA 510(k) & regulatory consulting

ICON plc – Expert FDA 510(k) & Medical Device Regulatory Consulting

HP&M – FDA 510(k) & regulatory consulting

EAS Consulting Group – Expert FDA Regulatory Consulting for Medical Devices

Food and Drug Law Institute (FDLI) FDA regulatory consulting for medical device companies

Medical Device Regulatory Affairs & QA Consultant | 4+ Yrs Exp | FDA 510(k) Submissions | Startups

RN, CCRC | Med Device & Pharma Law Expert | Clinical Trial Leader | Regulatory Submissions Specialist

Certified QA/RA Leader | 22+ Yrs Life Sciences | QMS, MDSAP, FDA, EU MDR | eQMS & Digital Compliance Expert

FDA 510(k) Regulatory Consulting Expert

FDA Regulatory Consultant | 510(k), De Novo, PMA | SaMD, Imaging, Digital Health

FDA 510(k) Regulatory Consulting & Legal Support | Oberheiden P.C.

Oriel STAT A MATRIX – FDA 510(k) & regulatory consulting expert

FDA 510(k) Consulting & Accredited Third Party Reviewer | 12 Years Experience