Soft bonecement for osteoporotic bone - CE application

Important results from the project

The purpose of the project was to strengthen Inossia´s expertise in quality systems and regulatory issues and to adapt Inossia´s quality system to their first customer. This has now been completed and all significant quality documents have been shared with and approved by the customer. The goal of the project is thus fulfilled.

Expected long term effects

The result of the project is that Inossia now has a quality system that makes it easier for the customer to approve Inossia as a critical supplier of the bone cement softener. It helps the customer to CE-certifiy the product containing Inossia´s softener. The expected effect in the short term is that the first product with Inossia softener will be launched on the EU market within 1 year from now. The expected effect on the 5-year term is that the degree of treatment of vertebral fractures in Sweden has increased significantly and that the product is sold internationally.

Approach and implementation

The entire work was divided in two phases to keep track of efficiency and budget and to make the most important and necessary first. The first phase included 209 consulting hours and generated training of Inossia´s owners and implementation and test driving of the new documents and working methods in the organization. Inossia also hired a business consultant to accelerate the cooperation with the customer which resulted in the work being completed much faster than expected.