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PQE Group

Regulatory Consultant

PQE Group is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With a strong focus on 510(k) submissions and strategic regulatory planning, they empower clients to navigate the complexities of FDA approvals.

Experience: 10+ years

Submissions: 35 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaIdeDe Novo

Device Specialties

CardiovascularOrthopedicNeurologyGeneral SurgeryGeneral Hospital

Executive Summary

Professional Overview

PQE Group is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With a strong focus on 510(k) submissions and strategic regulatory planning, they empower clients to navigate the complexities of FDA approvals.

Core Specializations

Regulatory Pathways

510kPmaIdeDe Novo

Device Specialties

CardiovascularOrthopedicNeurologyGeneral SurgeryGeneral Hospital

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Background: 10+ 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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