ITI’s medical products manufacturing has significant experience meeting the quality requirements for FDA listed products: soft-tissue lasers, medical protective anti-bacterial masks, and more. Medical products manufacturing has no room for deficiencies or mistakes. As the documentation, reporting, and importing requirements of FDA medical devices continue to increase in complexity, ITI is there to help navigate this process. Without a knowledgeable representative like ITI to guide your device through US Customs, the risk of an exam hold or shipment seizure increases dramatically.

In many cases, it’s necessary to contract with an offshore manufacturing facility that already has a valid FDA registration and product expertise. ITI is also registered with the FDA and can help facilitate the registration of a critical offshore factory where necessary. FDA registrations are an annual requirement. UDI compliance, which allows the global traceability of your medical device, may also be required. Additional auditing, registration, and testing required by other agencies, such as NIOSH and CDRH, are also common as well.

The medical experience of the ITI Manufacturing team gives customers dependable quality and relief. That is why multiple reputable companies that provide medical devices to doctors and the public choose ITI Manufacturing.