RTA & Deficiency Letter Consultants

Cruxi provides expertise in FDA QSR/QMS transition inspection readiness, ensuring compliance with regulatory requirements.

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

eQMS for life sciences teams and regulated products.

RQM+: FDA Regulatory Consulting for MedTech & Software Expertise

FDA 510(k) Consulting & Accredited Third Party Reviewer | 12 Years Experience

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

The FDA Group: Expert FDA Regulatory Consulting for Medical Devices

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

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

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

FDA 510(k) Regulatory and Quality Consulting Firm - 12 Years Experience

Expert FDA 510(k) Regulatory Consulting | Medical Device Academy

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

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

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

Expert FDA 510(k) Regulatory Consultant specializing in Ultrasound and Implant Devices | 20 Years Experience

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

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

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

FDA 510(k) Regulatory Consulting | Biostatistics & Testing Planning for Medical Devices

Expert FDA 510(k) Regulatory Consulting Firm | Global Testing & Training

Expert QA/RA Director | MedTech Product Launch | FDA, EU-MDR, MDSAP | QMS & Validation Specialist

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

Fang Consulting – FDA Regulatory & QMS Expert for Medical Devices

We are one of the leading medical device regulatory consultant in USA. We offer clients an array of services like turnkey services, system implementation, training, licensing, regu

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

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

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

FDA 510(k) & QMS Consulting for Class I/II Medical Devices | 12 Years Experience

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

FDA 510(k) Regulatory Consulting Firm | QMS | Class I & II Devices

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

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

FDA 510(k) Regulatory Consulting Expert

FDA 510(k) Regulatory Consulting & Legal Support | Oberheiden P.C.

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.

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

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.

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

Qmlogic offers specialized 510(k) submission services, guiding medical device companies through the FDA regulatory process to achieve market clearance.

ELS Group is a company with deep technical expertise and market access in Regulatory Affairs and Quality Assurance, duly certified. With 18 years of experience, we provide strategic solutions.

Assistance to initial importer and distributors

RegTrac is a global MedTech & Cosmetics regulatory partner simplifying compliance across product lifecycle offering strategy, submissions, QMS & PMS support with a scalable, right-first-time approach

BELAB SERVICES specializes in global regulatory consulting and other categories by facilitate market entry and compliance in over 30 countries, including EU, UK, US, Canada, Australia and the GCC

Compliance Insight offers expert FDA regulatory consulting for life sciences companies. They specialize in navigating complex regulations, ensuring compliance, and developing best practices for drugs, medical devices, and biologics.

Global Regulatory Partners (GRP) offers end-to-end regulatory affairs, clinical, quality, and pharmacovigilance services for medical devices, pharmaceuticals, cosmetics, and nutraceuticals. FDA U.S. Agent, 510(k) submission, PMA, regulatory strategy, and Q-Sub meeting support.

RAC-certified Regulatory Affairs professional with 7+ years of global experience in Class I, II, and III medical devices and IVDs, including software-enabled and digital medical devices.

IQVVV MedTech solutions are purpose-built for the medical device and diagnostics industry, spanning the entire product lifecycle from strategy and portfolio analysis to post-market.

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

FDA Compliance Group LLC offers FDA registration support, SOP development, FDA-483 and Warning letter responses, mock FDA inspections, gap analysis, and compliance training. Former FDA employees helping regulated industries achieve and maintain compliance.

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.

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

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

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

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

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

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

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

Ph.D. Scientific & Regulatory Consultant | Biomedical Expertise | Big Data Analysis | FDA Regulatory Affairs. https://drx2consulting.com/