Monroe Medical Device Consulting, LLC - 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
Monroe Medical Device Consulting, LLC
Description: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


Monroe Medical Device Consulting, LLC
319 Shilling Dr. ,
Somerset, NJ - New Jersey, United States
08873

Phone:
Fax:
888-834-1696
Email:

Website: http://www.monroemdc.net


Products and Services:


Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .Certified Quality Auditor | ASQ, License# 45739 June 2013-June 2017

FDA Accredited 510(k) 3rd Party Reviewer


Featured Products and Services

Monroe Medical Device Consulting, LLC -

Services Include  Remediation  Training  Quality Systems Auditing  Equipment Certification  QSR 820 & ISO 13485 Audits  Mock Audits & Audit Checklist  Quality Review Board  Process Verification & Process Validation  Global Regulatory Consulting  Independent Reviews for 510'K Submissions  Short & Long Term Regulatory Strategies  Registrations & Device Submissions  Ensure GMP Requirements  Management Review  QSIT training
Monroe Medical Device Consulting, LLC -
Qualifications  Certified Quality Auditor | ASQ, License# 45739 June 2013-June 2017  FDA Accredited 510(k) 3rd Party Reviewer  Grant: National Institute of Health,1997 - Communication Disorders High Resolution MRI of Cochlear Fluid Motion  Grant: National Institute of Health, September 1993 -MRI in Sensorineural Hearing Loss with 500mm Resolution