RQM+
RQM+ is a full-service MedTech CRO specializing in FDA regulatory consulting, with a strong focus on software expertise. They assist medical device companies in navigating complex FDA regulatory pathways, including 510(k) submissions, De Novo applications, and Premarket Approval (PMA). RQM+ serves clients globally and helps them achieve successful market access.
Experience: 15+ years
Expertise & Specializations
Regulatory Pathways
Executive Summary
Professional Overview
RQM+ is a full-service MedTech CRO specializing in FDA regulatory consulting, with a strong focus on software expertise. They assist medical device companies in navigating complex FDA regulatory pathways, including 510(k) submissions, De Novo applications, and Premarket Approval (PMA). RQM+ serves c...
Core Specializations
Regulatory Pathways
Services Offered
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Background: 15+ years of regulatory experience.
Cruxi view
RQM+ is a MedTech CRO specializing in regulatory consulting. Without specific details from the 'About' and 'Services' sections, a comprehensive analysis is limited. However, their LinkedIn presence suggests a focus on helping MedTech companies navigate the regulatory landscape.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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