Medical Device Commercialization Overview

Filing with Regulatory Agencies

Can your product be put on the market?

Securing the clearance of the controlling regulatory authorities is the last hurdle to be overcome before you can market your medical device for sale. Early in the design process you should have developed a strategy for obtaining eventual regulatory clearance. What remains is the actual submission of the clearance documents and the answering of any questions that might arise as the documents are reviewed.

Forma does not offer regulatory filing services in-house. However, we can partner with or refer you to companies that specialize in preparing the required filing documents. Those companies have extensive experience in putting together filings for many different types of medical products. They can also act as liaison with regulatory agency personnel, ensuring that the application process remains efficient.