Device Clinical Trials

As a leader in 3D visualization and pre-operative planning, M2S has over 10 years of medical device clinical trial experience working with leading device companies on IDE, pilot, pivotal and post-approval surveillance cardiovascular and orthopedic medical device clinical trials. M2S provides end-to-end clinical imaging services, from protocol development and IDE submission through post market surveillance. Our processes are GCP compliant and ISO 13485:2003 and 14971:2007 certified and our technology is proven, validated, and compliant with HIPAA and 21 CFR Part 11.   

Medical Device Clinical Trial Services

• Electronic Image Transfer
• Real-time, web-based data management and reporting
• Independent Radiological Review
• Advanced Image Analysis
  
• Quantitative Analysis
• Centralized Collection and access of Images with iMAS
• Post-Market Surveillance

Therapeutic Areas

Vascular/Cardiovascular

• AAA/TAA Stent Graft 
• Peripheral Stent
  
• Cerebral Vascular Stent
  
• CV Implants

Orthopedic  

• Fracture Healing
• Spinal Implants
  
• Joint Replacement 
• Osteobiologics
• Cartilage Repair
• Bone Healing
• Sports Medicine

Combination Drug/Device

Gastrointestinal

Urologic

For more information how M2S can help with your medical device or combination product clinical trials, contact us.