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Strengthened competency prior to commercialization

Reference number
Funding from Vinnova SEK 180 000
Project duration October 2017 - June 2018
Status Completed
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.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 25 November 2019

Reference number 2017-04912

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