MedTech4Health competence support for Native Bionics
|Coordinator||Native Bionics Scandinavia AB|
|Funding from Vinnova||SEK 200 000|
|Project duration||October 2018 - April 2019|
|Venture||Medtech4Health: Competence Enhancement in SME|
|Call||Medtech4Health: competence enhancement for smaller companies|
Purpose and goal
The goal of this project was to prepare all of the necessary setup, testing, and documentation enabling MedTech CE certification of Surf. This meant in practice that Native Bionics together with experts has acquired MedTech specific quality assurance system, work on product assessment and validation, executed scientific literature analysis and prepared for future clinical trial.
Expected results and effects
Native Bionics together with hired external consultants Anna Lampel and from SYMBIOTEQ have carried out product evaluation, prepared scientific literature analysis, quality systems and documentation eg. risk analysis, as well as planning for clinical studies. The overall project´s goals have been completed even if the result has not finally led to the actual CE marking. Project outcome lied ground for future clinical tests.
Planned approach and implementation
Without Medtech4Health financing support for the costs of external consultants from SYMBIOTEQ and Anna Lampel (the ergonomic specialist) Native Bionics would have never been able to carry out such thorough work prior to MedTech CE certification of SURF. Native Bionics now has a comprehensive understanding of which areas should be further analsed to succeed in the MedTech certification process. The project took longer than initially planned but it also led to a positive results in form of extended data collection during the product´s validation processes.