Profiles Of Success
Paladin Medical® is your champion for product success.
Not all regulatory consultants have the hands-on engineering, development, and executive management experience of Paladin Medical® as you can see in our Profiles of Success. We played a significant role in each of these successful outcomes. Please be aware that confidentiality agreements preclude us from discussing details.
Contact us for more information on these and other applications.
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
Biomaterials: Polymers, Surface Modifications and Combination Products
• Qualification and validation strategies for new and replacement biomaterials
• Silicones
• Polyurethanes
• Surface coatings
• PMMA
• Polyester
• Combination drug/device
• ISO-10993 biocompatibility testing optimization for all types of devices
• Surgical mesh materials, physical, animal, clinical testing and premarket applications.
• Expert Witness concerning design control and review compliance for mesh implant trials
• Cranioplasty plates, 3D manufacturing.
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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
• Cranial Plates
• Artificial joints
• Wedge osteotomy PEEK implant and instrumentation
• Bone growth stimulation
• Foot reconstruction systems
• Hip implants and joint resurfacing
• Intramedullary rod alternatives
• Foot implant for Correction of Hallux Vagus deformity
• Spinal implant technologies in clinical trial, IDE applications and premarket submissions
• Rods and screw
• Total artificial disc
• Spinal nucleus devices
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Dental
• Bone and Defect Filler
• Dental Implants
Electrophysiology – Cardiovascular and Neurological
• Implantable defibrillators
• AED and multifunctional electrodes
• ECG Electrodes
• 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
• Hyperthermia System using Airflow
• Cerebral Spinal Fluid Filtration
• Automated ankle/brachial pressure index measuring device
• Intercranial neurological interface device
• Cranial replacement device
• Mechanical tapping device
• Plethysmographs
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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
• Specialty Surgical Instruments
• Reusability protocols for cleaning and sterilization validation
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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
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Oral Appliances
• Qualifying biomaterials and device designs
• Premarket notification [510(k)] for Australian and US clients
• Bite guards, TMJ and bruxism
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Powered Mobility, Prosthetics and Physical Medicine
• Powered stand-up wheelchair
• Physical medicine devices for the home
• Materials qualification for prosthetic interface
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Reusability of Devices and Instrumentation
• Validated cleaning and/or sterilization studies
• Durability and reuse testing protocol development
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Safety Syringe
• Clinical usability testing
• Premarket notification [510(k)]
• Nitrile gloves
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Software, Electronics, Internet Medicine
• Implantable electronic device premarket notification [510(k)]
• Data storage systems
• Cybersecurity, software submission requirements
• Imaging diagnostic systems, such as gamma camera
• Radiology quality system device
• Software-based medical systems
• Hololens2 display/3D imaging
• Tablet-platform multiple diagnostic systems
• Internet-based home medical services
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Sterility and Shelf-life Testing
• Shelf-life testing and expiration-date labeling protocols
• Qualifying materials and devices for use in alternative sterilization methods
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Urological and Dialysis Catheters
• Clinical trial management, auditing and reporting
• Design qualification and review for numerous
• IDE applications and FDA interactions
• Premarket notification [510(k)] catheters
• FDA clearance of novel PU improved Foley catheter
• Biomaterials qualification
• Percutaneous implant port for bladder
• Anti-infective coatings and surface modifications
• Testing to voluntary standards
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Usability Studies
• Protocol development and field testing for user manual validations
• Usability studies for “over-the-counter” products
• Usability studies for safety syringes
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Vascular Grafts and Stents
• Peripheral vascular grafts
• Coronary artery bypass grafts
• Vascular stents technology
• Cell-seeding technology
• Tissue-derived vascular prostheses
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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.
For more details about our many services and customized training, please contact us. Please connect with us on LinkedIn