Provision Consulting Group (PCG) — 510(k) & De Novo Consultant (General-hospital/Cardiovascular)
Regulatory Consulting Firm
Provision Consulting Group (PCG) is a US-based FDA regulatory consulting firm with 12 years of experience, specializing in FDA 510(k) regulatory consulting for medical devices and other products. They offer expert guidance to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PCG serves clients globally and is dedicated to providing specializ...
Experience: 12+ years
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
Provision Consulting Group (PCG) provides regulatory consulting services to clients in:
Executive Summary
Professional Overview
Provision Consulting Group (PCG) is a US-based FDA regulatory consulting firm with 12 years of experience, specializing in FDA 510(k) regulatory consulting for medical devices and other products. They offer expert guidance to help medical device companies successfully navigate FDA regulatory pathway...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
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, APAC, EU, CA, MEA
- Background: 12+ years of regulatory experience.
Cruxi view
Provision Consulting Group (PCG) is a highly valuable regulatory partner for medtech companies, leveraging 12 years of focused experience to navigate the FDA clearance process. Their core strength is a deep mastery of the 510(k) pathway, supported by robust expertise in De Novo submissions, Q-Sub interactions, and IDEs. The firm demonstrates exceptional breadth, with proven capabilities across a wide array of device panels including Cardiovascular, Orthopedic, IVD, and SaMD/Digital Health. PCG provides a comprehensive, end-to-end service model that covers everything from initial pathway assessment and predicate analysis to full submission authoring and QMS implementation. This full-lifecycle support, combined with their global client reach, establishes them as a reliable and deeply knowledgeable firm for achieving commercialization goals.
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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