Knowledge for FDA application

Purpose and goal:

The purpose of the project is to hire an expert to support the company in seeking FDA approval for the medical device ReLink. The goal is for the company to compile the product´s data in a time- and cost-effective manner into a technical file to be submitted to the FDA for review. During the course of the project, the company´s quality management system will be updated to meet FDA regulations.

Expected results and effects:

The result of the project will be partly a technical file for ReLink, compiled and submitted to the FDA, partly an updated quality management system. An important effect of the project will be that the company, during the course of the project, will learn to navigate the FDA´s system and how this can be applied to the company´s existing and future products and product categories.

Approach and implementation:

The project begins with a feasibility study which includes various analyses and comparisons as well as a gap analysis of the company´s quality management system compared to the FDA´s regulations. The next step is to compile the technical documentation and, if necessary, supplement it with additional data. Finally, the technical file will be submitted and the quality management system updated.