Utveckling av ett patientanpassat kranioplastikimplantat

Purpose and goal

The project aimed at developing a production process and a technical file for a custom device cranioplasty product, including an approval from MPA. The activities in the project aimed at validating and building a manufacturing line and a quality system connected to a novel technology for cranioplasty. The aims have been achieved.

Results and expected effects

The project has resulted in significant value increase in OssDsign, the basis for future growth of the company is based upon validated materials, processes and quality systems. During the project time line the company has gained significant growth in turn-over and personnel.

Approach and implementation

As also mentioned in the interim report, the project has followed the submitted plan but with the change that OssDsign has taken responsibility for future manufacturing and CE marking of standard mosaics. DS´s efforts related to materials and methods for validation of raw materials was been expanded beyond the original project plan.