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.