FDA Approvals

Stamp of Approval
We managed the FDA approval and ongoing compliance processes for a medical product sold world-wide

Medical device manufacturers must comply with FDA regulations to legally market a product in the United States. These regulations require initial approval to begin marketing, as well as ongoing surveillance by the FDA. For many products, a 510(k) approval demonstrating essential equivalence of the product to other already approved devices and technologies allows for marketing to begin. But the regulations also require that the manufacturer implement and maintain a Quality System that specifies how the company operates and documents many facets of its operations.

This quality system must demonstrate regulatory compliance in areas such as new product R & D processes, purchasing requirements, manufacturing procedures, adequate and competent personnel, internal audits, regular management reviews, contract sales processes, etc. This can be a daunting task for new medical device manufacturers. Further, the company must be prepared for audits by the FDA. STI has years of experience with FDA approvals, quality system regulation, and FDA audits, and can help you navigate FDA regulatory processes, so contact us today!