Medical Devices
Bustos Law Group offers a full suite of legal and FDA consulting compliance services relating to medical device compliance. Medical devices are defined by the Food, Drug and Cosmetic Act as, “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory … intended for use in the diagnosis of disease or other conditions . . . or intended to affect the structure or any function of the body.” Medical Devices are regulated by class. These classes range from Class I to Class III which is the most highly regulated. Medical device compliance is vital before heading to market.
How it Works
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Medical Devices Services
Classification
GUDID (Global Unique Device Identification Database)
Premarket Approval
Quality System Regulation compliance
De Novo
Label Reviews
Premarket Clearance (510k)
Registration & Listing
Facility Audits
Marketing Reviews
QSR Compliance
UDI (Unique Device Identification)
Why Choose Us for FDA Compliance
We are a Texas-based regulatory compliance firm dedicated to providing personalized legal guidance, including FDA regulations for dietary supplements products and supplement compliance.
Simple Pricing & Payment
Personalized Guidance & Service
Modernized Process & Technology
Quality Service & Experience
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
