Strengthened competency prior to commercialization
|Coordinator||TEN MEDICAL DESIGN AB|
|Funding from Vinnova||SEK 180 000|
|Project duration||October 2017 - June 2018|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The aim of the project was to obtain regulatory approval for NAFT as well as prepare the implementation of a management system to ensure that 10MD meets specified quality requirements. In addition to achieving the objectives of the project, the staff at 10MD have gained significantly increased competence regarding quality and regulatory processes.
Expected results and effects
The objectives of the project were achieved and 10MD now has all regulatory approvals needed to start sales as well as succeed in market introductions.
Planned approach and implementation
Action points from previous work with the technical file were defined and corrected. It included, among other things, a quality management system. There was also a need to gain in-depth understanding of how the company would prepare for future regulatory requirements according to a new standard.