Implantable De Novo Consultants

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

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

Freyr Solutions – Expert FDA Regulatory Consulting for Medical Devices

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

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) & De Novo Consulting for Medical Device Startups | DocLab Inc.

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

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

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

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

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

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

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

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

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

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...

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

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

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.

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

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

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

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

35+ year RA/QA expert & ex-Notified Body Auditor specializing in global submissions (FDA, EU MDR, MDSAP) & QMS for...

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

Regulatory Affairs Expert - Medtech Compliance & Strategy

Regulatory Affairs & Quality Specialist for Medical Devices. Expertise in FDA/Health Canada submissions, QMS (ISO...

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

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

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