Let Paladin Medical be your champion for product success.

Not all regulatory consultants have the hands-on engineering, development, and executive management experience that Paladin Medical does. Some of the many contributions we’ve made to the medical device industry are detailed in the following brief Profiles. We played a significant role in each of these successful outcomes. Please be aware that confidentiality agreements preclude us from mentioning some specifics here. Contact us for more details.
 

  • Artificial Hearts, Heart Assist and Heart Valves +

    • Heart valves
      • Durability testing
      • Failure analysis
      • Flow simulation
    • Pericardial heart valve animal testing
    • Artificial heart clinical research and IDE submissions
      • Jarvik-7
      • Dayton Axial-flow pump
      • 3M/Pierce-Donachy
      • Milwaukee Heart

  • Polymer Biomaterials, Surface Modifications and Combination Products +

    • Qualification and validation strategies for new and replacement biomaterials
      • Silicones
      • Polyurethanes
      • Surface coatings
      • Combination drug/device
    • ISO-10993 biocompatibility testing optimization for all types of devices
    • Surgical mesh materials, physical, animal, clinical testing and premarket applications

  • Bone Graft Substitutes, Restorative Materials and Devices, Implants +

    • Orthopedic and dental biomaterial applications, clinical trial, IDE and premarket submissions
      • Coatings
      • Bone graft substitutes
        • Hydroxyapatite
        • Calcium sulfate and variations
      • Artificial ligaments
      • Artificial joints
      • Wedge osteotomy PEEK implant and instrumentation
    • Bone growth stimulation
    • Dental implants
    • Hip implants and joint resurfacing
    • Intramedullary rod alternatives
    • Spinal implant technologies in clinical trial, IDE applications and premarket submissions
      • Rods and screw
      • Total artificial disc
      • Spinal nucleus devices

  • Electrophysiology – Cardiovascular and Neurological +

    • Implantable defibrillators
    • Pacemakers
    • Leads and electrodes
    • Wearable external pacemakers
    • Electrophysiology stimulators
    • Ablation catheters
    • Guidewires and catheter navigation systems
    • Pacing systems for congestive heart disease
    • Bone and muscle electrical stimulation

  • Minimally Invasive Technology +

    • Laparoscopic, arthroscopic, spinal and other minimally invasive technologies 510(k) notifications
    • Qualification of unique materials and design features
    • Protocol development and testing requirements
    • Animal and clinical evaluations
    • Reusability protocols for cleaning and sterilization validation

  • Ophthalmology and Otolaryngology +

    • Selection of biomaterials, device qualification, and clinical trials
    • Comparative testing of lenses for optical quality related to clinical outcomes
    • Cochlear implant devices investigational applications

  • Powered Mobility, Prosthetics and Physical Medicine +

    • Powered stand-up wheelchair
    • Physical medicine devices for the home
    • Materials qualification for prosthetic interface

  • Reusability of Devices and Instrumentation +

    • Validated cleaning and/or sterilization studies
    • Durability and reuse testing protocol development

  • Safety Syringe +

    • Clinical usability testing
    • Premarket notification [510(k)]
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For more details about our many services and customized training, please contact us.
Confidentiality agreements obligate that we omit client names from these profiles.