Orthopedic PMA Consultants

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

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

RQM+: FDA Regulatory Consulting for MedTech & Software Expertise

MCRA – Expert FDA Regulatory Consulting for Medical Devices

Freyr Solutions – Expert FDA Regulatory Consulting for Medical Devices

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

Regulatory Compliance Associates – FDA Regulatory Consulting for Medical Devices

Elexes – 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

Lachman Consultants: Expert FDA Regulatory Consulting for Medical Devices

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

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

Expert Regulatory Services for Drugs, Biologics, and Devices

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

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

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

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

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

eQMS for life sciences teams and regulated products.

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

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

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

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

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

Lexology – FDA 510(k) & Regulatory Consulting

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

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

Lachman Consultant Services, Inc. – FDA 510(k) & regulatory consulting for medical devices

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

Leavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation

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

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

FDA Regulatory Consultants: 510(k), De Novo, PMA for Medical Devices. Global Reach.

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

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

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

Translational Medicine & Regulatory Affairs Executive | 15+ Years | Drugs, Biologics, Devices, IVDs

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

EAS Consulting Group – Expert FDA Regulatory Consulting for Medical Devices

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

Fang Consulting, Ltd. – FDA 510(k) & regulatory consulting | Quality Assurance | Risk Management

If your device is intended to diagnosis a disease or other health conditions, or if your device is involved in the cure, mitigation, treatment, or prevention of disease, or if your device is intended to affect the structure or any function of the body, then...

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

Fda510kconsulting offers expert 510(k) submission services, guiding medical device manufacturers through the FDA approval process for the US market.

Accortoreg offers specialized 510(k) submission services, guiding medical device manufacturers through the FDA approval process. Leverage their expertise for efficient and compliant submissions.

To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions

Cardiomedllc offers specialized 510k submission services for medical devices. They help navigate the FDA approval process efficiently.

mdi Consultants offers expert FDA regulatory compliance services, specializing in U.S. Agent representation for foreign medical device, pharmaceutical, and food manufacturers. They ensure seamless communication and compliance with FDA regulations.

Senior Regulatory Affairs Leader | Combination Products | Digital Health | Global Submissions

Expert in Drug Discovery, Medical Devices (IVDR), and Regulatory Affairs with 15+ years experience

Expert FDA Regulatory Compliance Consultant | QMS, Audits, 510k, PMA, Global Submissions | 15+ Yrs Exp.

Medical Device Regulatory & Clinical Affairs Expert | 30+ Yrs Exp | FDA Submissions | Global Approvals | QMS

25+ Yrs MedTech Leader: Regulatory, Clinical, Product Dev, AI, SaMD, Cybersecurity. Global Approvals.

30 Years FDA Regulatory & QA Expertise | 510k, PMA, QMS, Audits | Radiology, IVD, Orthopedic

Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.

Expert Regulatory Affairs Leader | Global Approvals | Devices, Biologics, Gene Therapies | FDA & EMA Navigation

Expert FDA Regulatory & Clinical Consultant | Driving Medtech Innovation from Strategy to Submission.

Ph.D. Scientific & Regulatory Consultant | Biomedical Expertise | Big Data Analysis | FDA Regulatory Affairs

Expert FDA & EU MDR Regulatory Strategist | Quality Systems Specialist | Global Market Access