CE mark application Zolidd®

Reference number 2018-04568
Coordinator Addbio AB
Funding from Vinnova SEK 194 950
Project duration December 2018 - June 2019
Status Ongoing
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.

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