OssDsign is an innovator, designer and manufacturer of implants and material technology for bone regeneration. We are surgeons, scientists and engineers - committed to improving outcomes in cranioplasty and facial reconstructive surgery.


By combining clinical insight with proprietary material technology and patient-adapted design, OssDsign supplies an expanding range of tailored solutions for cranial repair and facial bone reconstruction. OssDsign’s technology is the result of collaboration between clinical researchers at the Karolinska University Hospital, Stockholm, and material science experts at the Ångström Laboratory at Uppsala University.

THE HISTORY OF OSSDSIGN

The story of OssDsign begins with surgeons at Karolinska University Hospital in Stockholm, who in 2009 were facing challenges managing patients with the use of existing technologies and implants. The surgeons chose to collaborate with material researchers at Uppsala University in the search for a technical platform that could lead to a clinical solution for these extremely challenging patients. The collaboration led to the development of an innovative technology platform for regenerative, patient-specific implants.
The initial focus for this platform technology has been for patients suffering from complex cranial and facial defects. Many implant technologies are associated with high rates of costly complications and patient suffering. OssDsign’s commitment is to reduce these complications to improve clinical outcomes for patients - the results so far have led to a high level of both customer and patient satisfaction.

OSSDSIGN TODAY

  • Headquarters in Uppsala, Sweden. Founded in 2011 based on research collaboration between Karolinska University Hospital and Uppsala University
  • Global presence with established commercial organizations and partners in Europe, US, Israel and South-east Asia worldwide
  • In-house manufacturing of custom-made patient specific implants based on CAD technology and 3D-printing
  • Quality Management Systems compliance:
    • ISO13485:2016 Quality System Certification.
    • Medical Device Regulation (MDR) 2017/745
    • Full compliance to US FDA (21 CFR Part 820, 807, 801 and 803).
    • Japan Medical Device Regulations.
    • Medical Device Act 21012 in Malaysia
    • Health Products (Medical Devices) Regulations 2010 in Singapore
    • DNDM/MINSA Regulatory Requirements
  • Regulatory approvals and product certifications in:
    • Europe 
    • US 
    • Japan
    • Israel
    • Singapore/Malaysia
    • Panama


THE FUTURE OF OSSDSIGN

Our current focus is to become the leading provider of regenerative products for cranial and facial repair, based on our innovative technology platform. At the same time, innovation never stands still - new regenerative products for a variety of clinical applications are in development and clinical testing phases.