RQ

RQM+

Regulatory Consultant

RQM+ leverages extensive regulatory experience, including a former FDA regulatory specialist background, to provide expert consulting services. They specialize in 510(k) submission authoring, comprehensive regulatory pathway assessments, and detailed predicate device analysis. Their expertise also encompasses ISO 13485 Quality Management System consulting, FDA mock audit and inspection readiness, ...

Experience: 15+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoIde

Device Specialties

General HospitalCardiovascularOrthopedicNeurologyGastroenterology

Credentials & Recognition

Professional Experience

Former FDA Regulatory Specialist
Verified FDA experience
Former Notified Body Auditor
EU MDR expertise

Executive Summary

Professional Overview

RQM+ leverages extensive regulatory experience, including a former FDA regulatory specialist background, to provide expert consulting services. They specialize in 510(k) submission authoring, comprehensive regulatory pathway assessments, and detailed predicate device analysis. Their expertise also e...

Core Specializations

Regulatory Pathways

510kPmaDe NovoIde

Device Specialties

General HospitalCardiovascularOrthopedicNeurologyGastroenterology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
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

  • Former roles: Former FDA regulatory specialist.
  • Background: 15+ years of regulatory experience.

Cruxi view

RQM+ is a MedTech CRO that offers regulatory, quality, and compliance consulting for medical device and diagnostics companies. They have a large team with former FDA, MHRA, and notified body regulators, providing extensive expertise in navigating complex regulatory pathways.

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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