SaMD Classification 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

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

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

Leavitt Partners: Expert FDA Regulatory Consulting for MedTech Innovation

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

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

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

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.

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

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

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

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

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

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.

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

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

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

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

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

Expert in Regulatory Information Management (RIM) & Innovation | FDA/Global Compliance | System Analysis & Optimization

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

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

Regulatory Affairs Consultant for Medical Devices and Cosmetics

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

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

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

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