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

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Medical Technology Services

At MMDC, we focus on continuous improvement through internal and external training, internal audits, self-assessments, and industry-recognized certifications. MMDC maintains the highest level of expertise to stay at the forefront of medical technology that's always on the cutting edge.

Complete Services

We prepare FDA 510(k) for class I and II medical devices and coordinate pre-market authorizations (PMA) for the FDA. Additionally, we prepare submissions for Class I, II & III for Health Canada and Class I, IIA, IIB, and III for the EU. Our services include:

  • 510(k) Medical Device Consulting
  • Technical Documentation (EU/MDR)
  • Global Regulatory Consulting
  • Short & Long Term Regulatory Strategies
  • GMP Requirements
  • Medical Device Licenses (MDL) Canada
  • FDA QSR 820 & ISO 13485 Audits
  • Independent Reviews for 510(k) Submissions
  • Registrations & Device Listings

Regulatory Affairs

  • Regulatory Compliance
  • Regulatory Submissions (510(k), MDL, Technical Files)
  • Regulatory Strategy Development
  • New Product Development Pathways
  • Combination Product Strategy Development

Quality Assurance Processes

  • Remediation Strategies
  • Corrective and Preventive Action (CAPA)
  • Medical Device Reporting (MDR)
  • Device History Files (DHF)