REGULATORY WORK AS A FUTURE COMPETITIVE FACTOR

1.96M kr SEK

Funder	Vinnova
Recipient Organization	Health Solutions Svenska Ab
Country	Sweden
Start Date	Oct 01, 2021
End Date	Mar 31, 2022
Duration	181 days
Number of Grantees	1
Roles	Principal Investigator
Data Source	Swedish Research Council
Grant ID	`2021-03406_Vinnova`

Grant Description

Purpose and goal: ** Denna text är maskinöversatt **

Through this project, the company is now more ready to take on an MDR certification for class 2a products. The project means that processes and routines are updated and that quality work is improved, which means that we increase the quality of our products and deliveries. Expected results and effects:

** Denna text är maskinöversatt **

Health Solutions is now better equipped for the continued quality work. Through this project, this effect has been achieved in a much shorter time than if we had carried out the project without support from Hans Broström from Scilea. Approach and implementation: ** Denna text är maskinöversatt **

The project has been carried out in three work packages (AP), in AP1 a GAP analysis has been carried out which formed the basis for the remaining APs, I AP2 has workshops and weekly meetings carried out, to increase knowledge about relevant standards led by Hans Boström from Scilea AB. This has been a very rewarding way to carry out the project.

Under AP 3, the knowledge has been translated into concrete work to update and renew the quality system and the technical file.