Monroe Medical Device Consulting LLC
 
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Marketing, Business & New Product Development


At Monroe Medical Device Consulting® LLC we work with public and private companies to help you introduce medical devices into the marketplace. Our goal is to ensure that your device meets all regulatory requirements for FDA, HC, and EU. As an exFDA 3rd Party Reviewer, MMDC possesses over 15 years of experience in the Regulatory Industry.

New Product Development

• Specializing in regulatory strategies, we assist clients in the following markets: FDA, Health Canada, and the European Union. Our objective is to get you medical device into the market place by developing well structured regulatory strategies, and leveraging years of experience within the medical device industry.
• Centrally located in Somerset, NJ, we have easy access to the FDA and other regulatory authorities.
• We will work close with the FDA on your 510(k) medical device if a pre-submission is required.
• Our international experience will help to introduce your medical device into the market by partnering with you.

Product Development

Marketing & Labeling Compliance Review

• We provide a complete review of promotional marketing materials, user manuals, device and box labels to ensure compliance with applicable country specific regulations. We partner with translation companies if your labeling has specific language requirements. Contact MMDC today to schedule a consultation.

Business & Marketing Development

• As an expert in the medical device consulting industry we off competitive proposals with excellent outcomes:
    • 510(k) Medical Device Consulting for the FDA
    • Medical Device Licenses for Health Canada
    • Technical Files for the EU
• We assess your potential medical device and develop domestic (FDA's 510(k)) and international regulatory strategies to align with your company's business goals and objectives. Contact MMDC today to schedule a consultation.

Contact Monroe Medical Device Consulting® LLC for more information regarding our extensive regulatory services.