MEDICAL DEVICES
Comprehensive FDA medical device compliance services including establishment registration, U.S. Agent representation, 510(k) submissions, QSR (21 CFR Part 820) support, MDR reporting, labeling review, and inspection readiness for Class I, II, and III manufacturers.
Strategic regulatory pathways for Class I, II, and III medical devices. We ensure your products meet all FDA requirements for safe and effective market entry.
We support your establishment end-to-end—from registration and product listing through post-market compliance—to meet every U.S. FDA requirement.
510(k) Premarket Notification
Preparation of traditional, abbreviated, and special 510(k) submissions to demonstrate substantial equivalence.
Start SubmissionQMS & 21 CFR 820
Development and implementation of Quality Management Systems (QMS) compliant with FDA Quality System Regulations.
Build Your QMSU.S. Agent Representation
Mandatory U.S.-based representation for foreign device manufacturers to manage all FDA communications.
Appoint AgentEstablishment Registration
Annual management of facility registration and device listing to maintain an active status in the FDA database.
Register NowUDI & GUDID Support
Ensuring compliance with Unique Device Identification (UDI) labeling and GUDID database submissions.
Ensure UDI ComplianceDe Novo Classification
Strategic pathways for novel low-to-moderate risk devices that lack a predicate but do not require a PMA.
Evaluate PathwayPremarket Approval (PMA)
Rigorous regulatory support for Class III high-risk devices requiring extensive clinical data for FDA approval.
PMA ConsultingLabeling & IFU Review
Regulatory review of device labels, Instructions for Use (IFU), and marketing materials for FDA compliance.
Review LabelsMedical Device Reporting
Implementing post-market surveillance and mandatory adverse event reporting (MDR) systems.
Manage ReportingFDA Inspection Readiness
Mock audits and gap analysis to prepare your facility for routine FDA Quality System inspections.
Prepare for AuditRecommended Reading
U.S. FDA Initial Importer Service for Medical Devices
Learn how domestic and foreign medical device manufacturers, exporters, distributors and brand owners can establish a qualified Initial Importer in the United States.
This guide explains the Initial Importer’s FDA responsibilities, the benefits of working with an experienced U.S. FDA Consultant, and the differences between an Initial Importer, U.S. Agent and Importer of Record.
Practical guidance for manufacturers and exporters placing FDA-regulated medical devices on the U.S. market.
What You Will Learn
Initial Importer Responsibilities
Understand establishment registration, complaint procedures, Medical Device Reporting coordination, recordkeeping and FDA communication responsibilities.
Initial Importer vs. Importer of Record
Review the differences between the FDA-regulated Initial Importer role and the customs entry responsibilities of an Importer of Record.
Foreign Manufacturer Compliance
Learn how foreign manufacturers can coordinate U.S. importer activities while retaining responsibility for product quality, labeling and regulatory compliance.
FDA Consultant Support
Discover how an FDA Consultant can assist with registration, listed devices, complaint handling, MDR coordination, inspections and ongoing compliance.
Professional Initial Importer Service
The service is available to domestic and foreign medical device manufacturers and exporters that require an experienced United States-based Initial Importer for one or multiple medical device products currently listed with the U.S. FDA.
Trusted U.S. Agent
Helping medical device manufacturers achieve FDA compliance for Class I, II, and III devices.
1. What is a Medical Device U.S. Agent?
A mandatory representative for foreign firms, acting as the primary liaison with the FDA.
2. How is device classification determined?
Based on risk level: Class I (low), Class II (moderate), and Class III (high/life-sustaining).
3. What is a 510(k) submission?
A notification showing a device is "substantially equivalent" to a legally marketed predicate.
4. When is PMA required?
For high-risk Class III devices that require rigorous clinical data for safety and efficacy.
5. What is the FDA QSR (21 CFR 820)?
The Quality System Regulation governing manufacturing processes and design controls.
6. What is Establishment Registration?
Annual registration for any facility involved in producing or distributing medical devices.
7. How does Device Listing work?
Each device type must be listed in the FDA database linked to its manufacturing facility.
8. What are UDI requirements?
Unique Device Identification labels are required for tracking and post-market safety.
9. What is a De Novo pathway?
For novel, low-to-moderate risk devices that lack a clear predicate device.
10. What is an IDE?
Investigational Device Exemption allows for clinical trials of unapproved devices.
11. What is MDR reporting?
Mandatory reporting of device-related deaths, serious injuries, or specific malfunctions.
12. Are Class I devices exempt?
Many are exempt from 510(k) but must still meet general controls and registration.
13. What is the GUDID?
The global database where manufacturers submit mandatory UDI information.
14. What are MDUFA fees?
User fees paid to FDA for registration and specific application reviews.
15. How do I get Small Business status?
By certifying gross receipts are below $100M to receive significant fee discounts.
16. What is the Official Correspondent?
The person designated to manage the establishment's registration and listing entries.
17. What are Design Controls?
Procedures to ensure that device specifications meet user needs and intended uses.
18. What is a 513(g) request?
A formal request to FDA for guidance on how a specific product will be classified.
19. Is software (SaMD) regulated?
Yes, if the software performs medical functions like diagnosis or treatment optimization.
20. What is an FDA 483?
A list of observations made by an investigator during an inspection of your facility.
21. How long is 510(k) valid?
It does not expire unless the device is significantly modified or the FDA changes rules.
22. What is Post-Market Surveillance?
Active monitoring of device performance and safety once it is commercially available.
23. What is biocompatibility?
Evaluation of the material's compatibility with human tissue (ISO 10993 standards).
24. When is the renewal period?
Establishment registration must be renewed annually from Oct 1 to Dec 31.
25. Do importers need to register?
Yes, initial importers must register, though they generally do not list products.
26. What is a Letter to File?
Documentation for minor changes that don't trigger a new 510(k) submission.
27. Can FDA inspect foreign plants?
Yes, FDA conducts inspections globally to verify compliance with the QSR.
28. What are labeling requirements?
Labels must include directions, warnings, and manufacturer contact information.
29. What is a Predicate Device?
A legally marketed device used as a comparison for a 510(k) submission.
30. What is a Warning Letter?
A formal notice for serious violations that requires immediate corrective action.
31. What is ISO 13485?
An international QMS standard that is increasingly aligned with FDA regulations.
32. How do I start the process?
Identify your classification and establish a compliant Quality Management System.