Monroe Medical Device Consulting, LLC

Overview

Providing Regulatory, Quality, Auditing Medical Device Expert Service Device Certification:

Certified Quality Auditors over see relationships with clients performing gap assessment, determing observations and findings, and areas requiring remediation. We will work with your organization to perform total quality system, department, desktop, internal, and supplier quality audits. We work directly with clients to establish Quality Agreements.

Development & Marketing:

Through careful audits and reviews, MMDC helps to introduce new products into the marketplace with minimal time to market. Our primary goal is to ensure that your device meets all regulatory requirements by eliminating non-conformance.

Experience You Can Depend On:

Backed by strong experience in both quality management review and global regulatory affairs, we provide clients with fast, efficient, and accurate services. MMDC is committed to ensuring regulatory clearance and compliance with domestic and international rules and regulations. Contact MMDC at (877) 783-2104 , for more information regarding request for proposals and regulatory services.

Take your business to the next level with Monroe Medical Device Consulting, LLC, in Somerset, New Jersey. We specialize in electro-mechanical software driven complex medical devices with a proven track record. James W. Monroe, our owner, is a certified quality auditor specializing in complex regulatory services and works with a team of highly skilled and qualified staff. Our staff continually refines it's skills to meet the ever changing regulatory environment

Standards & Methodologies

Monroe Medical Device Consulting, LLC has not posted any Methodologies at this time.

Qualifications, Certifications, Accreditations & Licenses

Certified Quality Auditor | ASQ, License# 45739 June 2013-June 2017

FDA Accredited 510(k) 3rd Party Reviewer