(September 26, Odense): Ossiform® is pleased to announce that it has obtained the ISO 13485 certification through BSI (The British Standards Institution). ISO 13485 is the medical device industry’s internationally harmonized standard for quality management system requirements specific to medical devices.  

Obtaining the ISO 13485 certification is an important milestone that demonstrates Ossiform’s dedication to ensuring the highest quality and safety standards in the design, production and provision of its bone implants. The third-party certification has been granted upon demonstrating that Ossiform’s quality management processes, procedures, and technical documentation meet or exceed the internationally agreed requirements for medical devices.  

The certification is an important step toward bringing Ossiform’s P3D Bone to market and into first clinical use. 

“We have implemented the standard’s requirements in our quality management system (QMS), and I am pleased and proud on behalf of Ossiform that our organization, QMS processes, and production environment are now aligned and in compliance with ISO 13485. We will continue to improve our processes, QMS, and products – in line with the standard’s requirements and intention.” says Bibi Klingenberg, Quality Assurance Manager. 

“The certification is central in our endeavor to rethink the future of healthcare solutions, and challenge the status quo, by making bone implants personalized while facilitating the natural forming of new bone. With the certification, we will continue our task to develop and provide patient–matched, bone regenerative healthcare solutions to improve the quality of life for people with bone defects.  
We can now say, We Print Bone™, in the highest quality” says Chief Technical Officer, Martin Bonde Jensen.