Increase competence within Spectronic Medical regarding regulatory approvals

Important results from the project

The purpose of the project was to acquire the knowledge required to write and submit an application to the United States Food and Drug Administration (FDA) regarding a medical device. An approved such application is a prerequisite for selling and marketing a medical device product in the US.

Expected long term effects

The result of the project has been very successful and the company is now well equipped for future FDA applications. For the company, this is extremely important as an FDA approval is a prerequisite for being able to market the company´s current and upcoming products in the United States.

Approach and implementation

During the project, external experts have been consulted to guide and support the company´s FDA related work. The experts have carried out training of the company´s staff as well as consultancy concerning the work to be performed, both with regard to documentation and quality management.