Sanrubio, Llc

Sanrubio LLC, provides specialized regulatory consulting for medical devices, guiding companies through the FDA regulatory process in the United States. Our services encompass preparation and submission of 510(k), De Novo, and Pre-Submission filings. Additionally, we offer expert consulting to ensure compliance with international standards such as ISO 13485, MDSAP, and 21 CFR 820. In an industry where quality and safety are paramount, our multidisciplinary team is equipped to design tailored strategies that deliver value and build trust.