IVD PMA 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

Global Regulatory Compliance Experts. Since 1978, Lachman Consultants has offered compliance, regulatory affairs, and technical services to pharmaceutical, medical device, and biologics clients worldwide.

FDASpecialist provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs. Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning. Led by Richard Chiang, Owner and Chief Consultant.

MCRA – Expert FDA Regulatory Consulting for Medical Devices

eQMS for life sciences teams and regulated products.

NAMSA: FDA 510(k) Regulatory Consulting Expert | 15 Years Experience | Global Support

RQM+: FDA Regulatory Consulting for MedTech & Software Expertise

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

Freyr Solutions – Expert FDA Regulatory Consulting for Medical Devices

The FDA Group: Expert FDA Regulatory Consulting for Medical Devices

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

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

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

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

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

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

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

Axeon LLC – FDA 510(k) & Regulatory Consulting | 20 Years Experience

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

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

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

Expert Regulatory Services for Drugs, Biologics, and Devices

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

PCG – U.S. FDA Regulatory Consulting for Medical Devices

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

MedTech Regulatory & Project Leader | Combination Products | 510(k) & EU MDR | QMS & Validation Expert

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

Fang Consulting – FDA Regulatory & QMS Expert for Medical Devices

Regulatory Compliance Associates – FDA Regulatory Consulting for Medical Devices

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

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...

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

FDA 510(k) Regulatory Consulting Expert

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

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

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

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

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

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

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

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

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

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.

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

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 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.

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

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

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

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

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