MedQAIR

Regulatory Consultant

MedQAIR is a consulting firm specializing in FDA 510(k) regulatory consulting for international medical device manufacturers. Their services include 510(k) submissions for Class I and Class II general hospital devices, helping clients achieve successful market clearances.

Experience: 12+ years

Submissions: 10 510(k)

Professional Overview

MedQAIR is a consulting firm specializing in FDA 510(k) regulatory consulting for international medical device manufacturers. Their services include 510(k) submissions for Class I and Class II general hospital devices, helping clients achieve successful market clearances.

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Regions: US, EU
• Background: 12+ years of regulatory experience.

Cruxi view

MedQAIR, a consulting firm with 12 years of dedicated experience, offers a highly specialized focus on FDA 510(k) regulatory consulting. Their unique value lies in expertly guiding international medical device manufacturers, particularly those in the EU, through the US FDA 510(k) pathway. They possess specific expertise in traditional 510(k) submissions for Class I and Class II general hospital devices, providing a targeted and efficient approach to achieving successful market clearances for clients seeking entry into the US.

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