What services does PCG offer?

PCG 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 PCG specialize in?

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

What is PCG's regulatory experience?

PCG has 7+ years of experience, 15+ 510(k) submissions in FDA regulatory affairs.

PCG

Q: What regions does PCG serve?

PCG provides regulatory consulting services to clients in United States (FDA).

U.S. FDA Regulatory Consulting Firm

PCG is a dedicated U.S. FDA regulatory consulting firm specializing in comprehensive support for medical device companies. With 7 years of experience, PCG excels in navigating the complexities of FDA regulatory pathways, including 510(k) submissions, de novo applications, PMA, and investigational device exemptions (IDE). Their expertise encompasses regulatory submissions, quality management system...

Experience: 7+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPmaIdePre-Submission

Device Specialties

CardiovascularOrthopedicNeurologyGastroenterology

Regions Served

PCG provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPmaIdePre-Submission

Device Specialties

CardiovascularOrthopedicNeurologyGastroenterology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

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

Regions: US
Background: 7+ years of regulatory experience.

Cruxi view

This firm's strength lies in its focus on U.S. FDA regulatory consulting. However, without more information, a detailed analysis is difficult.

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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