Increase competence within Spectronic Medical regarding regulatory approvals
|Coordinator||SPECTRONIC MEDICAL AB|
|Funding from Vinnova||SEK 196 500|
|Project duration||November 2016 - November 2017|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
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 results and 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.
Planned 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.