Every medical device shipped to the United States must be cleared for compliance by Food and Drug Administration (FDA) officers at the port of entry. Improper paperwork, company registration, or coding can cause serious setbacks to clinical trial and commercialization efforts.
To ensure that your product arrives on-time and is usable in the US, Endurant Medical Logistics partners with Medical Device Post Production Services (MDPPS), a reputable FDA-licensed initial importer whose founder and team have decades of hands-on expertise in medical device development, software verification, and risk assessment. MDPPS serves as a reliable interface between your device manufacturers and the FDA—both at ports of entry and with the FDA themselves. Here’s what you can expect from MDPPS:
robust SOPs that address every possible contingency, including customer complaints and medical device reports (MDRs).
verification that your manufacturers are properly registered with the FDA, and coached on how to consistently create accessible and FDA-compliant labeling so your shipments are never held.
credentialed access to FDA electronic systems ensures that all communication with the FDA is expedited and routed appropriately.
Best of all, Endurant doesn’t charge you for services you receive through MDPPS—but you get the benefit of priority importation service through our partnership. Contact us today to see how we can solve your importing issues.
