Monroe Medical Device Consulting LLC
 
Card Payments

Call (877) 783-2104

Or (908)809-0081


Monroe Medical Device Consulting® LLC Company

Specializing in Medical Device Regulatory Submissions


Monroe Medical Device Consulting® LLC:

Provide your patients with the best care possible by ensuring your medical device meets applicable regulatory requirements. Monroe Medical Device Consulting® LLC. We remain on the cutting edge of knowledge based technology and regulations through our memberships in professional societies, achieving recognized certificates and certifications, and actively serving on public policy committees.

We prepare FDA 510(k) for class I and II medical devices as well as coordinate pre-market authorizations (PMA), which is a more rigorous process for FDA. Additionally, we prepare submissions for Class I, II & III for Health Canada and Class I, IIA, IIB, and III for the EU.

MMDC is a Certified Quality Auditor that provides Internal Audits, Supplier Quality Audits, and total Quality Systems Audits to the FDA QSR and ISO 13485:2003 and Health Canada.


Area of Expertise:

  • Radiology (MRI, CT, Ultrasound, PET
  • Nuclear Medicine, X-Ray, PACS)
  • Lasers & Fiberoptics
  • In-Vitro Diagnostics
  • Infusion Pumps
  • All Electro-mechanical software driven devices
  • Endoscopic Devices
  • TENS Devices
  • Electro-Surgical Devices
  • Auditory Testing Devices
  • Catheters and Disposables

Mission

Monroe Medical Device Consulting® LLC. is dedicated to providing clients with the highest level of expertise with respect to Global Regulatory Submission and Strategies and Quality Assurance. We accomplish this through continuous training, education and professional certification for global regulatory and quality regulations.

Vision

To provide superior global quality and regulatory services to assist clients in achieving regulatory clearance, and to create quality products while reducing cost and time to market.

Values

  • Maintain highest level of expertise through continuing education, device training, continuous review of global regulatory and quality assurance standards, policies and guidance.
  • Multi-faceted business model that focuses on client centric need, compliance with domestic and international platforms while reducing time to market and commercialization.
  • Dedication. MMDC utilizes a client centric business model that focuses on the specific needs of each client, their potential medical device, key market indicators, and time to market and commercialization. Through stage gate defined regulatory strategy end points, we ensure the all regulatory and quality regulations and compliance issues are addressed early in the development stage. This allows the business to develop parallel strategies that both are country and client specific.
  • Continuous Improvement, through internal and external training, internal audits, self-assessments, and industry recognized certifications we will ensure that MMDC maintains the highest level of expertise to stay at the forefront of cutting edge technology and provide an avenue for innovation to be brought into the market place by our clients.


Our Goal:

  • Reduced time to market
  • Client focused synergistic time commitments
  • Expert regulatory quality submissions

For more information or to submit a request for proposal and regulatory services. Contact