What services does Ron Makar offer?

Ron Makar 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 Ron Makar specialize in?

Ron Makar specializes in 510k, Post Market and other FDA regulatory pathways for medical devices.

What is Ron Makar's regulatory experience?

Ron Makar has 20+ years of experience, 45+ 510(k) submissions in FDA regulatory affairs.

Ron Makar

Trainer & Consultant: FDA Medical Device Regulations, ISO 9001:2015, Internal & Lead Auditor

Ron Makar from Axeon LLC is a dedicated FDA regulatory consultant with extensive expertise in 510(k) submissions and post-market surveillance. He brings 20 years of experience in guiding medical device companies through complex regulatory landscapes.

Experience: 20+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPost Market

Regions Served

Ron Makar provides regulatory consulting services to clients in:

European Union (MDR/IVDR)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPost Market

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

Regions: EU
Background: 20+ years of regulatory experience.

Cruxi view

Ron Makar is a medical device consultant, trainer, and lead auditor at Axeon Corporation, specializing in FDA medical device regulations, ISO 9001:2015, and internal/lead auditing. He also has experience with Innovative Quality Consulting, LLC.

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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