HomeOur Services SAFETY AND PERFORMANCE EVALUATION OF MEDICAL DEVICES

SAFETY AND PERFORMANCE EVALUATION OF MEDICAL DEVICES

To support the various evaluations of the stated devices, MRIDA (a division of Palamur Biosciences) is equipped with sophisticated surgical interventional facility / equipment like Philips Azurion Cath Lab, Ventilator / Physiological Monitor, IVUS, OCT, Cardiac Doppler, Echocardiography, Cardiopulmonary Bypass, Defibrillator, Scanning Electron Microscope (SEM), etc.

Using these sophisticated facility MRIDA could carry out number of GLP studies with reference to implantable devices in cardiovascular section like coronary stents, peripheral vascular stents, ECMO pumps, LVAD, TAVR device, and ASD occlusion device.

Our experienced team has also the distinction of successfully executing studies for large equipment suits like ventilators; endoscopy suits and dialysis equipments etc for leading medical device companies like that of St. Jude Medical, Phillips, Leica, Abbot and others.

Preclinical services for performance, biocompatibility & safety evaluation of given medical devices and therapeutics (ISO 10993, ISO 25539-2: 2012 and 21 CFR 58 / GLP)
Cardiovascular segment devices
  • Cardiac rhythm / Flow management devices (Defibrillator & Pacemaker)
  • Interventional cardiac devices (Stents, Catheters & Angioplasty balloons)
  • Cardiac monitoring / diagnostic devices (Telemetry systems)
  • Peripheral vascular devices (Stents, Grafts & Balloon catheters)
  • Electrophysiological devices (RF ablation & laser catheters, 3D Mapping systems)
  • Prosthetic devices and ventricular function devices (Prosthetic valves & VAD)
Gastrointestinal segment devices
  • Nasogastric Tubes
Genitourinary segment devices
  • Urinary incontinence devices (macroplastique, urethral sling implants & nephrostomy tubes / urinary stents )
Neurological segment devices
  • Neuroplasty implants (Cochlear implants)
  • Renal denervation ablation devices (RDN catheters)
Dental devices
  • Endosteal / Endosseous
  • Single-Stage and subperiosteal dental implants
  • Subperiosteal dental implants
Integumentary implants devices /
therapeutics
  • Hemostats & Sealants
  • Cellular implant therapies for wound healing
Orthopedic segment
  • Tissue engineered grafts for bone defects (Arthroplasty tissue implants)
  • Knee replacement implants (Metal and Ceramic implants)
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