IVD 510(k) Consultants

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

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

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

Expert Regulatory Services for Drugs, Biologics, and Devices

Leavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation

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

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

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

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

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...

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

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

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

FDA 510(k) Regulatory Consulting Expert

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

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

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

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

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.

FDA 510(k) Regulatory Consulting for Global Medical Device Manufacturers - IVD Specialist

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

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...

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

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

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

Global Quality & Regulatory Affairs Leader | FDA & International Compliance | QMS Expert | Device & Combination Products

20-Year Medtech Quality & Regulatory Executive | Medical Device & IVD Expert

Expert Regulatory Affairs Consultant | 20+ Yrs PMA, IDE, 510(k), EU MDR | Global Strategy & Approvals