Medical Devices Services
Device Classification and Pathway Determination
GUDID (Global Unique Device Identification Database)
Medical Device Label Reviews
Premarket Clearance (510k)
FDA Device Registration & Listing
General Wellness Devices
Medical Device Marketing Reviews
Quality System Regulation compliance
Facility Audits
Medical Device Initial Importer Registration
Premarket Approval (PMA)
UDI (Unique Device Identification)
How it Works
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Why Choose Us for FDA Compliance
We are a Texas-based regulatory compliance firm dedicated to providing personalized legal guidance, including FDA regulations for medical and wellness device compliance.
Simple Pricing & Payment
Personalized Guidance & Service
Modernized Process & Technology
Quality Service & Experience
What Our Clients Say...
Excellent Law Service
"I contacted Heather to get overview about the FDA-compliance products to initiate my start up business of importing food product from Indonesia. Her response was very encouraging such that I decided to move forward with the plan. I ended up hiring her and she guided me in legal issue related to the importing process. With her guidance, I started my business, and now I have been able to import the products legally and I also have expanded the import for other product with new foreign supplier using the same procedure. Her service has initiated my starting point, which is a very critical stage."
- Foreign Food Startup Company Client
