CE mark application Zolidd®
|Funding from Vinnova||SEK 194 950|
|Project duration||December 2018 - June 2019|
|Venture||Medtech4Health: Competence Enhancement in SME|
|Call||Medtech4Health: competence enhancement for smaller companies|
Purpose and goal
The goal with the project is to prepare an application for CE mark of the medical device Zolidd® Dental, AddBIOs first product.
Expected results and effects
The experience generated will benefit AddBIO by establishing a quality system and knowledge that can be used when the company continues the product development with a complete product portfolio and introduction of new products on the market.
Planned approach and implementation
AddBIO needs to perform an analysis of the requirements for an CE mark application according to the new directive for medical devices, MDR (Medical Device Regulation (EU) 2017/745). With an improved competence in the field of quality and regulatory assurance, AddBIO will be able to perform a thorough analysis of what is required for applying for a CE mark for Zolidd® Dental according to the directives.