FDA market entry & submissions
Pathway strategy (510(k), De Novo, PMA), classification, Q-Sub, submission preparation and responses to FDA additional information requests.
Medical device & IVD regulatory consulting
US FDA market entry for medical device manufacturers — from first 510(k) to US Agent.
EU MDR / IVDR and international registrations, too.
Regulatory consultants in California, Paris and Shenzhen, working in English, Chinese and French, so your factory, your test labs and FDA stay on one plan.
Where we take your device
US FDA, EU MDR and EU IVDR — under one plan.
US FDA
FDA market entry
From classification to clearance, and US registration after it.
- 510(k), De Novo and PMA pathway strategy
- Pre-Submission (Q-Sub) with FDA
- Submission preparation and responses to FDA questions
- Establishment registration & device listing
CE marking under MDR
Regulation (EU) 2017/745 for medical devices and software.
- Technical documentation & GSPR
- Clinical evaluation
- ISO 14971 risk management files
- Post-market surveillance plans
- Direct work with notified bodies
CE marking under IVDR
Regulation (EU) 2017/746 for in vitro diagnostics.
- Technical documentation & GSPR
- Performance evaluation
- Risk management & PMS plans
- Direct work with notified bodies
- 3
- Regions — California, Paris, Shenzhen
- 3
- Working languages — English, Chinese, French
- 20+
- Countries and regions where our team has secured registrations
- QMSR
- Certified ISO 13485 internal auditors for QMSR and audit readiness
About us
Three regions, one team.
Reglo Medical Consulting LLC is a California-registered regulatory consulting company for medical device and IVD manufacturers, with representatives in the US, France and China working as one team.
Meet the teamWhen your day ends, ours is still going.
California
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Pacific Time
Paris
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Central European Time
Shenzhen
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China Standard Time
Every project has a lead and a second contact, chosen by where you are, and associate consultants support each representative. We work in English, Chinese and French.
Services
From first submission to life after approval.
Engage us for a single submission or a full market-access program, always under a written scope.
EU MDR / IVDR & CE marking
Technical documentation, General Safety and Performance Requirements (GSPR), clinical and performance evaluation, ISO 14971 risk management files and post-market surveillance plans. We work directly with notified bodies.
International registrations
Market sequencing, dossiers and submissions across North America, Europe, the Middle East and Asia, coordinated with your distributors. Country coverage is confirmed during scoping.
QMS, QMSR & audit readiness
FDA’s Quality Management System Regulation (QMSR, 21 CFR Part 820) took effect on 2 February 2026 and incorporates ISO 13485:2016 by reference. Our certified ISO 13485 internal auditors run QMSR gap assessments, update your procedures and prepare you for FDA inspections and notified body audits. Technical file review and team training.
IRB & clinical support
Institutional Review Board (IRB) packages and study documents, and clinical pathway design.
Additional services
Available on their own or alongside a project. Not every manufacturer needs them.
FDA registration, annual renewal & US Agent
For manufacturers outside the US: FDA establishment registration and device listing, annual renewal, and US Agent service. Registration must be renewed every year.
FDA FY2027 annual registrationNotary, apostille & translation
California notary public, apostille, and in-house translation of regulatory documents.
Why choose Reglo
Have you registered devices like mine?
Our team has filed across the categories below, from capital equipment and implants to wearable monitors, IVD and software.
Imaging & monitoring
CT, MRI, PET/CT, ophthalmic OCT, cerebral oximetry, wearable ECG, pulse oximeter and blood glucose monitoring devices
Surgical & therapeutic
Surgical robots and navigation, microwave and cryoablation, dental and aesthetic lasers, IPL
Critical care
Non-invasive ventilators, infusion and syringe pumps, blood warmers, neonatal incubators
Implants & passive
Hip and knee replacement systems, gastric balloons and bands, sterile syringes, ablation needles, PRP kits, device disinfectant
IVD
NT-proBNP heart failure assay, lab-on-chip and exosome microfluidic diagnostics
Software
Software as a Medical Device (SaMD), including medical image processing software
- Orthopedics
- Oncology
- Dental
- Aesthetics
- Ophthalmology
- Critical care
- Cardiology
How we work
Always know what comes next.
- 1
Introductory call
Your device, target markets and distributors.
- 2
Written scope
Deliverables, timeline and fee, agreed before work starts.
- 3
Plan & submit
One project plan with owners and dates, and regular updates.
- 4
Review & lifecycle
Regulator questions, then support after approval.
Which markets are next for you?
Tell us about your device and where you want to sell it. We will give you an honest view of the pathway and a first step.