What services does Innolitics offer?

Innolitics offers Regulatory Pathway Assessment, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Innolitics specialize in?

Innolitics specializes in 510k, De Novo and other FDA regulatory pathways for medical devices.

What is Innolitics's regulatory experience?

Innolitics has 12+ years of experience in FDA regulatory affairs.

Innolitics

Innolitics is a specialized FDA regulatory consulting firm with 12 years of experience, focusing on navigating the FDA 510(k) pathway for Software as a Medical Device (SaMD), AI/ML, and Imaging devices. They provide comprehensive services including 510(k) submissions and De Novo applications, guiding medical device companies through complex regulatory landscapes to achieve successful clearances. T...

Experience: 12+ years

Expertise & Specializations

Regulatory Pathways

510kDe Novo

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe Novo

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

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.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 12+ years of regulatory experience.

Cruxi view

Innolitics offers specialized expertise in navigating the FDA 510(k) pathway, particularly for Class II medical devices incorporating software, AI/ML, and imaging technologies. With 12 years of experience, their deep focus on software as a medical device (SaMD) and AI/ML applications provides a distinct advantage for companies developing cutting-edge technologies. Their fixed-project pricing structure offers predictability for clients. The firm's specialization in 510(k) and De Novo submissions indicates a strong understanding of premarket clearance requirements.

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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