James Harvey Knauss has years of experience in assisting companies with the regulatory maze associated with export and import of medical devices. He is listed with the FDA as a "United States Agent for Devices" as defined in Section 417 of the Modernization Act of 12997, for foreign companies that market medical devices in the United States.
EM2 Solutions is your complete source for quality, regulatory, and staffing support. EM2 provides customized support solutions to fit your immediate and long term needs. We can assist with short or long term projects or provide you the personnel to fill your temporary, temporary to direct and direct hire needs. Our expertise lies in the technical and scientific fields. Whether you are looking for a new career opportunity or personnel for your own organization, EM2 is ready to work for you.
Excel Regulatory Consulting provides regulatory consulting services to medical device companies to obtain FDA approval to market their products. These services include: regulatory strategy planning, submissions such as: 510(k), IDE, or PMA; and negotiation and liaison with FDA. We also assist medical device companies and contract manufacturers in the establishment of FDA-compliant Quality Systems.
