Who We Are
Synapse Strategies is a MedTech innovator focused on advancing orthopaedic care through imaging intelligence. We partner with clinicians to create software that enhances surgical planning and supports robotic-assisted procedures.
Our Mission
To empower surgeons performing knee, hip, and shoulder replacements with precise, objective, and clinically meaningful imaging data — enabling improved predictability and efficiency in the surgical workflow.
Driven by Collaboration
Our development teams include orthopaedic surgeons, radiologists, AI specialists, robotic engineers, and regulatory experts. This multidisciplinary approach ensures that our solutions are technically strong, clinically relevant, and regulatory-ready.
Orthopaedic Surgeons
Clinical Expertise
Radiologists
Imaging Analysis
AI Specialists
Machine Learning
Robotic Engineers
System Integration
Regulatory Experts
Compliance
Quality Without Compromise
Global Standards Compliance
Synapse Strategies adheres to global medical-device standards, ensuring safety, performance, and transparency throughout the product lifecycle.
- • ISO 13485 – Quality management for medical devices
- • IEC 62304 – Medical device software lifecycle
- • ISO 14971 – Risk management for medical devices
- • IEC 62366-1 – Usability engineering
Regulatory Excellence
Our regulatory positioning ensures that our technology meets the highest standards for medical device software.
- • FDA SaMD Guidance compliance
- • IMDRF Framework alignment
- • Safety and transparency principles
- • Clinical performance validation
Cybersecurity & Data Protection
Security and privacy are fundamental to our platform
Secure Data Processing
Encrypted data processing with industry-standard protocols
Complete Audit Trails
Access control, versioning, and comprehensive logging
FDA Compliant
Cybersecurity documentation aligned with FDA expectations