Regulatory Strategy & Compliance
Expert guidance through FDA 510(k), De Novo, PMA, and CE Mark pathways
Navigating the regulatory landscape for rare medical devices is complex. Our team provides expert guidance through FDA 510(k), De Novo, PMA, and CE Mark approval processes, ensuring that your product meets regulatory requirements efficiently.
Our Expertise
We specialize in guiding clients through the full spectrum of regulatory pathways, including:
- FDA 510(k): Pre-market notification process for devices that are substantially equivalent to a predicate device.
- De Novo Classification: A pathway for novel devices that are not substantially equivalent to existing devices.
- PMA (Premarket Approval): A more rigorous FDA process for high-risk devices that require extensive clinical data.
- CE Mark: Obtaining CE marking for devices to be marketed in Europe, ensuring compliance with EU regulations.