What services does Sigma Biomedical offer?

Sigma Biomedical offers Regulatory Pathway Assessment, 510(k) Submission Authoring and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Sigma Biomedical specialize in?

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

What is Sigma Biomedical's regulatory experience?

Sigma Biomedical has 12+ years of experience in FDA regulatory affairs.

Sigma Biomedical

Regulatory Consultant

Sigma Biomedical is a dedicated consulting firm providing expert FDA 510(k) regulatory consulting services. With 12 years of experience and deep regulatory knowledge combined with biomedical engineering expertise, they empower medical device companies to successfully navigate complex FDA regulatory pathways and achieve 510(k) clearances. Their focused approach ensures efficient and effective suppo...

Experience: 12+ years

Expertise & Specializations

Regulatory Pathways

510k

Regions Served

Sigma Biomedical provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

Services Offered

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.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US
Background: 12+ years of regulatory experience.

Cruxi view

Sigma Biomedical offers 12 years of experience specializing in FDA 510(k) regulatory consulting, enhanced by a biomedical engineering perspective. Their focus on traditional 510(k) submissions across all device classes (I, II, and III) indicates a broad understanding of the regulatory landscape. This combination of regulatory expertise and engineering knowledge allows them to provide comprehensive support to medical device companies seeking 510(k) clearance. Their fixed-project pricing structure offers clients budget predictability.

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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