What services does Qualio offer?

Qualio offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Qualio specialize in?

Qualio specializes in 510k and other FDA regulatory pathways for medical devices.

What is Qualio's regulatory experience?

Qualio has 5+ years of experience, 10+ 510(k) submissions in FDA regulatory affairs.

Qualio

Qualio offers expert guidance for medical device regulatory consulting firms, addressing key questions about their value and fees. They specialize in helping companies navigate the complexities of regulatory pathways.

Experience: 5+ years

Submissions: 10 510(k)

Expertise & Specializations

Regulatory Pathways

510k

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

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: 5+ years of regulatory experience.

Cruxi view

This blog post discusses the cost of medical device regulatory consulting in 2020. It aims to help companies determine if the fees are worth the value provided.

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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