CE mark application Zolidd®
|Funding from Vinnova||SEK 181 909|
|Project duration||December 2018 - June 2019|
|Venture||Medtech4Health: Competence Enhancement in SME|
Purpose and goal
The aim of the project was to prepare AddBIOs first Product, Zolidd Dental, for CE-marking under MDR. We have now made the changes required to be able to make an application under the new regulation.
Expected results and effects
We have started tha application process with our NB. We assume that they will start the work in Q4 2019/Q1 2020, and we will be able to continue the wotk to expand the AddBIO portfolio. The CE-mark will enable us to release the product to the european market, and the knowledge is now in-house and will facilitate future applications.
Planned approach and implementation
The project has been conducted according to the plan, including regulalry meetings and communications with our consultant that we hired with help of the fundings recieved from Vinnova. We have recieved the support needed to feel secure to handle this work in-house in the future.