FDA market entry & submissions
Pathway strategy (510(k), De Novo, PMA), classification, Q-Sub, submission preparation and responses to FDA additional information requests.
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.
After approval, we stay with you
Compliance continues long after the first clearance. We support the full product lifecycle.
- Registration renewals
- Post-market surveillance
- Vigilance & adverse event reporting
- Unique Device Identification (UDI) & EUDAMED
- Design change assessments
- Labeling & translation updates
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
Do you work with distributors?
Yes. We align with your distributors on requirements, documents and timelines so everyone works from one plan.
Who does the work?
Experienced regulatory affairs professionals. Translation is handled in-house; we coordinate test labs and work directly with notified bodies.
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.