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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®. 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 topics.

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

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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
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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
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
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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
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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
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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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)]
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Software, Electronics, Internet Medicine

Implantable electronic device premarket notification [510(k)]
Data storage systems
Imaging diagnostic systems, such as gamma camera
Software-based medical 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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Oral Appliances

Qualifying biomaterials and device designs
Premarket notification [510(k)]
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Urological and Dialysis Catheters

Clinical trial management, auditing and reporting
Design qualification and review
IDE applications and FDA interactions
Premarket notification [510(k)]
Biomaterials qualification
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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In-vitro fertilization products

In-vitro diagnostics

For more details about our many services and customized training, please contact us.

Confidentiality agreements obligate that we omit client names from these profiles.

Paladin Medical University of Kentucky Department of Biomedical Engineering Paladin Medical Society for Biomaterials Paladin Medical Regulatory Affairs Certification Paladin Medical American Institute for medical and Biological Engineering