Novella’s dedicated team serves only medical device and diagnostic companies. Led by a management team with over 25 years of operational leadership experience, each project team member is a fully dedicated device expert, and most have deep histories with sponsor companies. Our professionals understand the intricacies and nuances of device trials, and unlike many CROs, we have the global footprint, regulatory acumen and quality management systems to serve your trial well.

Medical Device experience spans the following:

 

  • 510(k)
  • Investigational Device Exemption (IDE)
  • Premarket Approval (PMA)
  • Feasibility/Proof-of-Concept
  • Pivotal
  • Post-Market Support/Registry
  • Health Economics & Reimbursement
  • Combination Products
  • Biologics
  • Human Factors
  • In Vitro Diagnostics
  • Companion Diagnostics

Novella serves the following therapeutic areas:

 

Medical Device Experience

Medical Device & Diagnostic Experience:

 

  • Ventricular Assist Devices (VADs)
  • Valves
  • Bare metal and drug-eluting stents
  • Stent grafts
  • Stem cells
  • Alginates
  • Pacemakers
  • Cardiac leads
  • Implantable Cardioverter-Defibrillators (ICD)
  • Neurovascular ultrasound transducers
  • Ablation catheters
  • Balloon catheters
  • Spine fixation hardware
  • Full and partial knee replacement hardware
  • Hip replacement device & hardware
  • Shoulder hardware
  • Spinal cord neurostimulator
  • Transdermal patch
  • Bone cement
  • Lumbar fusion device
  • Septal closure device