PQE Group
PQE Group is a dedicated regulatory and quality consulting firm with 12 years of experience specializing in FDA 510(k) submissions. They offer comprehensive, all-in-one solutions to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PQE Group serves clients globally, including in the US and EU, ensuring a thorough approach to regulatory compl...
Experience: 12+ years
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
PQE Group provides regulatory consulting services to clients in:
Executive Summary
Professional Overview
PQE Group is a dedicated regulatory and quality consulting firm with 12 years of experience specializing in FDA 510(k) submissions. They offer comprehensive, all-in-one solutions to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PQE Group s...
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.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Regions: US, EU
- Background: 12+ years of regulatory experience.
Cruxi view
PQE Group is a regulatory affairs consulting firm specializing in FDA 510(k) submissions. They offer services to medical device companies seeking regulatory approval in the US market.
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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