SLAM Orthopedic achieves CE certification for ADEPTH medical device
SLAM Orthopedic, winner of the Venture Challenge 2020, has successfully obtained CE certification for its medical device ADEPTH and has been awarded ISO13485 certification, marking a major milestone in the company’s development.
ADEPTH enables real-time depth measurement during bone drilling, allowing surgeons to quickly and accurately select the appropriate screw implants in fracture surgery. This innovation aims to improve surgical precision, streamline workflows, and ultimately enhance patient outcomes.
The certifications were achieved just 4.5 months after submission of the Technical Documentation to TÜV SÜD. This rapid process underscores the strong execution capabilities of the SLAM Ortho team and the maturity of the technology.
With these certifications in place, SLAM Ortho is now positioned to:
- Implement ADEPTH in hospitals
- Improve surgical workflows and decision-making
- Advance adoption of its technology in clinical practice
The process involved compiling an extensive technical file of over 1,800 pages, highlighting the scale of the effort required to meet regulatory standards. SLAM Ortho credits this achievement to the dedication of its team and the support of partners and stakeholders, including TÜV SÜD, MD squared B.V., YES!Delft, advisors, and investors.
As a Venture Challenge alumnus and winner in 2020, SLAM Ortho continues to demonstrate strong progress in translating innovative ideas into impactful medical solutions.
Congratulations to the SLAM Ortho team on reaching this important milestone!
