QU

Qualio

Regulatory Consulting Firm

Qualio is a leading FDA regulatory consulting firm with over 12 years of specialized experience dedicated to accelerating market access for innovative medical devices. Our expert team partners with medtech companies of all sizes to navigate complex regulatory landscapes, from initial strategy development and submission authoring to quality system implementation and post-market compliance. We deliv...

Experience: 12+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPost MarketQ Sub

Device Specialties

General SurgeryCardiovascularGastro Urology

Regions Served

Qualio provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Professional Experience

Former FDA Regulatory Specialist
Verified FDA experience

Executive Summary

Professional Overview

Qualio is a leading FDA regulatory consulting firm with over 12 years of specialized experience dedicated to accelerating market access for innovative medical devices. Our expert team partners with medtech companies of all sizes to navigate complex regulatory landscapes, from initial strategy develo...

Core Specializations

Regulatory Pathways

510kDe NovoPost MarketQ Sub

Device Specialties

General SurgeryCardiovascularGastro Urology

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.
  • Regions: US, EU
  • Background: 12+ years of regulatory experience.

Cruxi view

Qualio, a leading FDA regulatory consulting firm, stands out for its exceptional regulatory expertise, boasting over 12 years of specialized experience in accelerating market access for innovative medical devices. Their team has a deep understanding of FDA requirements, coupled with a proactive approach, making them a trusted choice for achieving regulatory success. With a strong track record of submitting 15 510k applications, they have demonstrated their expertise in navigating complex regulatory landscapes. Additionally, their ability to provide robust, efficient, and compliant solutions ensures clients achieve their regulatory goals with confidence and speed. Qualio's services cater to medtech companies of all sizes, offering a wide range of expertise, including pathway assessment, classification assessment, and predicate analysis. Their commitment to delivering high-quality solutions and adapting to the evolving regulatory environment makes them an invaluable partner for medtech professionals.

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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