ClinDatrix is well-versed in the design and systems engineering development of electro-mechanical medical devices. Our historical experience includes prototyping, pilot production, full production, design validation, process validation, software validation, clinical trials, 510k or PMA submission and post release support. We understand your development processes as they relate to the need for clinical trials.
Among projects that we have worked on are the following:
CARDIOVASCULAR
- Blood Pumps
- High Speed Holter ECG Analysis
- High Speed Holter Pacemaker Analysis
- Holter Monitors and Scanners
- Pacemakers
- Platelet Collection and Aggregation
- Post Surgical Red Blood Cell Processing
CLINICAL CHEMISTRY
- High Volume Blood Chemistry Analyzers
GASTROENTEROLOGY
- Fiber-Optic Endoscopes
- Tissue Morcellation via Laparoscopy
- Ultrasonic Abdominal Imaging
OPHTHALMOLOGY
- Cataract Surgical Systems
- Contact Lenses
- Intraocular Lens Implant
- Radial Keratotomy
- Vitreo-Retinal Surgical Systems
MEDICAL AESTHETICS
- Breast Implants
- Dermal Fillers
MUSCULOSKELETAL
- Knee Replacement
- Tendon Replacement
NEUROSTIMULATION
- Spine
- Vagus Nerve
- Deep Brain (DBS)
OBESITY INTERVENTION
- Adjustable Gastric Banding Systems
- Intragastric Balloon system
NEUROLOGY
- Intracranial Pressure Monitoring
OBSTETRICS
- Fetal Oxygen Monitoring
ONCOLOGY
- Oncology Agent Infusion Pumps
- Thermoradiotherapy
PULMONARY
- Patient Ventilators
- Pulmonary Dynamic Compliance Computer