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 Servicesdevice clinical trials


Therapeutic Areasstent device clinical trials

Vascular/Cardiovascular

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

 

Orthopedic  

  • Fracture Healing orthopedic device trialsspine orthopedic device trials
  • 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.