RTA & Deficiency Letter Consultants

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

MCRA – Expert FDA Regulatory Consulting for Medical Devices

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

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

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

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

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

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 |...

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

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

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

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

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

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

Medical Device Regulatory Expert | 25+ Years Experience | FDA, EU MDR, Risk Management, 510(k), ISO 14971

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.

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.

VerusFDA specializes in 510(k) submission services, guiding medical device manufacturers through the FDA approval process. They offer expertise to ensure compliance and successful market entry.

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

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...

CMC Regulatory Affairs Expert specializing in Drug Master Files (DMF) submissions to USFDA, EU, and global authorities

Regulatory professional with expertise in EU MDR/IVDR & FDA compliance for medical devices, IVDs, and pharmaceuticals.

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

Expert QMS & ISO 14971 Risk Management Pro | EU MDR, SaMD, IVD Compliance | 10+ Yrs MedTech Experience

Regulatory Affairs Expert - Medtech Compliance & Strategy

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.

25+ Years QA/RA Leadership: FDA & Intl. Submissions, Inspections, Medical Devices & Comb. Products

FDA 510(k) Regulatory Consulting Expert | Medical Devices | Provision Consulting Group

Regulatory Affairs Specialist with 9.5 years of experience in medtech.

Expert SaMD & AI/ML Regulatory Strategist | FDA 510(k), PMA, EU MDR/IVDR | 8+ Years Experience

Expert FDA Regulatory Reviewer with 10+ years at FDA, specializing in IVDs, risk assessment, and pathway strategy.

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