FDA Medical Device Registration

Navigating FDA regulatory requirements can be a daunting task, but RQMIS is here to ease that burden. We offer comprehensive support for a variety of FDA administrative activities across medical devices, drugs, combination products, cosmetics, and nutraceuticals.

Our team of FDA Subject Matter Experts brings unparalleled regulatory knowledge and hands-on experience to every project. Unlike large registration firms, we combine cost-efficiency with deep regulatory expertise, ensuring your product’s compliance and smooth progression along its regulatory path.

With RQMIS, you have a partner who is not only knowledgeable but also accessible—we’re just a phone call away. Let us handle the complexities of FDA compliance so you can focus on bringing innovative products to market.

FDA Small Business Services

If your business qualifies as a Small Business under the FDA Small Business Discount (SBD) Program, you could benefit from significantly reduced user fees for certain FDA registrations and renewals.

According to the FDA, a small business is defined as one, including its affiliates, with gross receipts and sales under $100 million for the most recent tax year.

The Benefits Are Clear:

Under the 2025 FDA User Fee Schedule, a qualified small business could save over $18,000 on a 510(k) submission alone compared to the standard fee.
These savings extend across various application types, providing critical financial relief for emerging and growing businesses.

How RQMIS Can Help:

Our FDA SBD Program Consultants are here to guide you through the qualification process:

Assess your eligibility for the SBD program.
Assist with the FDA Small Business Certification Request (Form FDA 3602).
Maximize cost savings across your regulatory submissions.

Navigating the FDA's requirements can be complex, but RQMIS ensures your business benefits from every available advantage. Let us handle the details, so you can focus on innovation and growth.

Connect with our SBD experts today and start saving on your FDA submissions!