SLAM Ortho B.V.
SLAM Orthopedic is a pioneering medical device company focused on developing innovative sensor technologies to support surgeons during orthopedic procedures. Their mission is to enhance surgical precision, improve patient outcomes, and seamlessly integrate advanced data-driven solutions into clinical workflows. Their vision is to add smart technology to existing surgical instruments, providing real-time data and insights to surgeons for better decision-making and patient care.
Industries
Nr. of Employees
small (1-50)
Products
Automated intraoperative screw-length measurement system (in development)
An add-on sensor system for standard surgical drills that measures and automatically reports the required screw length during fixation procedures; designed for contactless measurement and compatibility with existing drill machines.
Automated intraoperative screw-length measurement system (in development)
An add-on sensor system for standard surgical drills that measures and automatically reports the required screw length during fixation procedures; designed for contactless measurement and compatibility with existing drill machines.
Services
Clinical trial support and in-OR device integration
Planning and executing pilot and first-in-patient studies, training surgical teams, collecting procedural data, and translating clinical feedback into product requirements.
Regulatory and QMS consulting for medical devices
QMS maintenance, regulatory submission preparation, internal audits, supplier oversight, and support for conformity to EU MDR, ISO 13485, FDA standards and risk management (ISO 14971).
Mechanical R&D, prototyping and design-for-manufacture
Concept generation, detailed mechanical design, optomechanics, prototyping and testing, and preparation of drawings and specifications for manufacturing.
Clinical trial support and in-OR device integration
Planning and executing pilot and first-in-patient studies, training surgical teams, collecting procedural data, and translating clinical feedback into product requirements.
Regulatory and QMS consulting for medical devices
QMS maintenance, regulatory submission preparation, internal audits, supplier oversight, and support for conformity to EU MDR, ISO 13485, FDA standards and risk management (ISO 14971).
Mechanical R&D, prototyping and design-for-manufacture
Concept generation, detailed mechanical design, optomechanics, prototyping and testing, and preparation of drawings and specifications for manufacturing.
Expertise Areas
- Intraoperative sensor systems for orthopedics
- Clinical trial management for medical devices
- Regulatory compliance and QMS for medical devices (EU MDR, ISO 13485, FDA 21 CFR Part 820)
- Mechanical design and prototyping for medical instruments
Key Technologies
- Intraoperative sensor modules
- Bone density sensing during drilling
- Add-on drill-system integration
- Sterile reusable device housings