Maven Profcon Services LLP — 510(k) Consultant (IVD)
Regulatory Consultant for Medical Devices
Maven Profcon Services LLP is a dedicated consulting firm specializing in FDA 510(k) regulatory support for global medical device manufacturers. With 12 years of experience, they offer expert assistance for traditional 510(k) submissions for Class I and Class II medical devices, with a strong focus on In Vitro Diagnostic (IVD) products. Maven Profcon Services LLP is committed to helping medical de...
Experience: 10+ years
Submissions: 10 510(k)
Expertise & Specializations
Regulatory Pathways
Device Specialties
Executive Summary
Professional Overview
Maven Profcon Services LLP is a dedicated consulting firm specializing in FDA 510(k) regulatory support for global medical device manufacturers. With 12 years of experience, they offer expert assistance for traditional 510(k) submissions for Class I and Class II medical devices, with a strong focus ...
Core Specializations
Regulatory Pathways
Device Specialties
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.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Background: 10+ years of regulatory experience.
Cruxi view
With 12 years of dedicated experience, Maven Profcon Services LLP provides highly specialized regulatory support for medical device manufacturers navigating the FDA 510(k) pathway. Their core strength lies in a deep and focused expertise on traditional 510(k) submissions, particularly for Class I and Class II devices, backed by a successful track record of 10 submissions. While they possess a strong specialization in In Vitro Diagnostic (IVD) products, their experience extends across a diverse range of medical specialties including orthopedic, cardiovascular, and radiology. What truly sets them apart is their focused service offering, which covers the critical early stages of regulatory approval, from initial pathway assessment and predicate analysis to comprehensive 510(k) authoring. This makes them an invaluable partner for companies seeking expert guidance to build a robust and successful submission from the ground up.
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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