NAMSA

NAMSA is a leading full-service CRO with 15 years of experience, specializing in FDA 510(k) regulatory consulting for medical device companies. Their dedicated team expertly guides clients through complex FDA regulatory pathways, ensuring successful 510(k) clearances for Class I, Class II, and Class III devices. With extensive experience in IVD and Radiology, NAMSA offers comprehensive support glo...

Experience: 15+ years

Professional Overview

NAMSA is a leading full-service CRO with 15 years of experience, specializing in FDA 510(k) regulatory consulting for medical device companies. Their dedicated team expertly guides clients through complex FDA regulatory pathways, ensuring successful 510(k) clearances for Class I, Class II, and Class...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Regions: US, EU
• Background: 15+ years of regulatory experience.

Cruxi view

NAMSA distinguishes itself as a large, full-service CRO with 15 years of experience, specifically specializing in FDA 510(k) regulatory consulting. Their dedicated 510(k) regulatory consulting team provides comprehensive support for medical device companies, guiding them through complex pathways to achieve successful clearances. With expertise spanning Class I, Class II, and Class III devices, and specialized knowledge in IVD and Radiology, NAMSA offers a robust solution for diverse product types. Their global reach, serving clients in the US, EU, and globally, further enhances their capacity to handle international regulatory challenges and provide integrated solutions.

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