The FDA No Longer Requires Paper Submissions.                                                                                                     The FDA No Longer Requires Paper Submissions.

Monroe Medical Device Consulting, LLC

Ph: (908) 300-3854

Fax: (908) 768-3318

Mon - Sun: 8:00 AM - 8:00 PM

About Us

Monroe Medical Device Consulting, LLC (MMDC) specializes in making sure your medical device meets all applicable regulatory requirements. We're based in Dunellen, New Jersey, and offer nationwide, as well as international services. We pursue excellence in providing high-quality medical device regulatory submissions. Our areas of specialization include US-FDA traditional 510(k), special 510(k), abbreviated 510(k), and PMA pre-submissions. With Health Canada, we handle class I, II, and III submissions and with the European Union, offer class I, IIa, and IIb submissions.

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Our founder, James W. Monroe, MS, CQA, is a certified quality auditor specializing in regulatory submission and quality auditing. James holds Bachelor's and Master's Degrees in Electrical Engineering and has two research grants from the National Institutes of Health. He has authored several publications, and has over 20 years of hands-on experience in medical device development and software. His expertise has allowed him to work in other medical device arenas with infusion pumps, lasers, electro-stimulators, and liposuction devices.

At MMDC, our well-rounded team is ready to meet your needs. As a former third-party FDA reviewer, James has a clear understanding of how the FDA thinks and how to demonstrate substantial equivalence, even with the most challenging of medical devices.

MMDC is dedicated to providing clients with the highest level of expertise concerning global regulatory submission and strategies and quality assurance. We accomplish this through continuous training, education, and professional certification for global regulatory and quality regulations. Contact MMDC now to learn more...

See Our Body of Work.

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  • Regulatory Affairs Professionals Society (Regulatory Affairs Certification)
  • American Society for Quality (Certified Quality Auditor)
  • The Advanced Medical Technology Association (AdvaMed)
  • Institute of Electrical and Electronics Engineers