Monroe Medical Device Consulting LLC
 
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Take your business to the next level with Monroe Medical Device Consulting® LLC. MMDC works with a team of highly skilled and qualified staff members to reduce your time to market and commercialization. Our staff continually refines its skills to meet the ever changing regulatory environment. We specialize in electro-mechanical software driven complex medical devices with a proven track record.

Training

Training

Consulting

Consulting


MMDC Management

Founder & CEO:


James W. Monroe, MS, CQA

James W. Monroe is a certified quality auditor specializing in regulatory submission and quality auditing. James holds a Bachelor's and Master's in Electrical  Engineering, has two Research Grants from the National Institutes of Health, several publications, and over 15 years of hands on experience with developing medical devices and software. His experience has allowed him to work in other medical device arenas including: infusion pumps, lasers, electro-stimulators, and lipo-suction devices. He works extensively with a well-rounded team to meet the client's needs. As a former 3rd Party FDA reviewer he has a very clear understanding of how the FDA thinks and how to demonstrate substantial equivalence, even with the most challenging of medical devices.

Draft

Director of Quality


Martha Howard

Martha Howard comes to MMDC with over 27 years of experience in the pharmaceutical and biotech industries. She attend The University of Medicine and Dentistry of New Jersey and also received her Certification as a clinical research associate (CRA) and clinical research organization (CRO) from Raritan Valley College in 2007. Martha is also a Quality Assurance and Systems expert with extensive experience in creation and maintenance of quality system documentation for Class I, II and III sterile medical devices and in Human Tissue.

Previously served as quality representative overseeing the implementation and integration of parent company’s quality system to ensure compliance with domestic and international quality and regulatory rules and requirements. Martha’s background includes experience with internal audits, FDA regulatory and site inspection. She also brings to MMDC experience in European and Worldwide quality system standards such as ISO 9000, 9001 and 13485. She also has a high level of experience working with contract manufacturers to ensure that products are manufactured in compliance with US and international quality system requirements.

Control

Director of Marketing


Jeanne Upthegrove, BA

Jeanne holds a bachelor’s degree from Rutgers University. Her main objective is to help  clients successfully prepare their medical device(s) for introduction into interstate commerce. As both a business entrepreneur and banking industry professional, she brings her sales and marketing experience to the Director of Marketing position at MMDC. Through her extensive travel in the US, Canada and Europe Jeanne has a thorough understanding of different cultures that enables her to interact effectively and develop relationships with a variety of clients. Jeanne creates opportunities and takes calculated risks to bring business to the next level. As a mother and business woman, she has been able to balance her life by prioritizing, multi-tasking and managing responsibilities. She brings all of these qualities to this position and will work with the team at MMDC to give devices a client centric focus.

Online Marketing