Monroe Medical Device Consulting LLC
 
Card Payments

Call (877) 783-2104

Or (908)809-0081


Medical Device Consulting

Contact MMDC at  (877) 783-2104 in for more information regarding our Regulatory and Quality Professional Services

We are centrally located in Somerset, NJ, USA.

Services Include:

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

Regulatory Affairs:

• Regulatory Compliance
• Regulatory Submissions (510(k), MDL, Technical Files)
• Regulatory Strategy Development
• New Product Development Pathways
• Combination Product Strategy Development
• Canadian Medical Device Regulations (Canada CDMR)

Quality Assurance Processes:

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