Your Champion for Product Success

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 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

Read More

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.
Read More

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
Read More

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
Read More

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
Read More

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
Read More

Oral Appliances

• Qualifying biomaterials and device designs
• Premarket notification [510(k)] for Australian and US clients
• Bite guards, TMJ and bruxism
Read More

Powered Mobility, Prosthetics and Physical Medicine

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

Reusability of Devices and Instrumentation

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

Safety Syringe

• Clinical usability testing
• Premarket notification [510(k)]
• Nitrile gloves
Read More

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
Read More

Sterility and Shelf-life Testing

• Shelf-life testing and expiration-date labeling protocols
• Qualifying materials and devices for use in alternative sterilization methods
Read More

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
Read More

Usability Studies

• Protocol development and field testing for user manual validations
• Usability studies for “over-the-counter” products
• Usability studies for safety syringes
Read More

Vascular Grafts and Stents

• Peripheral vascular grafts
• Coronary artery bypass grafts
• Vascular stents technology
• Cell-seeding technology
• Tissue-derived vascular prostheses
Read More

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

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