ISOplan USA

Regulatory Lead

ISOplan USA is a dedicated consulting firm specializing in FDA 510(k) regulatory submissions and registrations. We empower medical device companies, particularly startups and SMEs, to successfully navigate the FDA regulatory landscape and achieve timely 510(k) clearances. Our focused expertise ensures a streamlined and efficient path to market for Class I and Class II devices.

Experience: 12+ years

Professional Overview

ISOplan USA is a dedicated consulting firm specializing in FDA 510(k) regulatory submissions and registrations. We empower medical device companies, particularly startups and SMEs, to successfully navigate the FDA regulatory landscape and achieve timely 510(k) clearances. Our focused expertise ensur...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Background: 12+ years of regulatory experience.

Cruxi view

ISOplan USA offers focused expertise in FDA 510(k) submissions, particularly for Class I and Class II medical devices. With 12 years of experience, they provide specialized consulting services to help medical device companies navigate the 510(k) regulatory pathway. Their specialization in traditional 510(k) submissions, coupled with a fixed-project pricing structure, can provide cost predictability for clients. While their listed specialties are broad ('other'), their website focus suggests a deep understanding of the 510(k) process.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.