Extensive Experience in the Evaluation of Medical Devices

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Our expertise ranges from early device iteration, optimization, and mechanistic studies aimed at driving differentiation in the marketplace, to large-scale GLP safety assessments for regulatory submissions.

State-of-the-art medical device testing

We profile the safety and efficacy of implanted devices and combination products, and develop novel testing and assessment procedures with multiple regulatory compliances.

  • Open paradigm of collaboration as a non-profit (501 C3) institute
  • Operational compliance and accreditation - GLP, OLAW, AAALAC
  • Animal sciences expertise - full-time ACLAM-certified DVMs
  • Experts in safety - full-time boarded DACVPs
  • Full histology suite for all phases of embedding, sectioning, staining and imaging

Fully-equipped operating suites

We enable complex surgical procedures in our state-of-the-art facilities.

  • Extensive surgical expertise in small and large animal models
  • Multiple, fully-equipped ORs with anesthesia machines, ventilators, hemodynamic and airway gas monitoring systems
  • Multiple surgery tables and hospital-grade fluoroscopy systems, including dedicated prep and recovery rooms for each suite
  • Catheterization lab
  • Adjoining conference facilities with 2-way video and audio

GLP-compliant imaging modalities

  • Laparoscopic/Endoscopic Olympus towers
  • OEC® Digital Fluoroscopy
  • GE Innova System/3-D Angiography
  • Computed Tomography (CT) and Optical Coherence Tomography (OCT)
  • EP Mapping and Electrophysiology
  • Ultrasound in a wide range of clinical applications, including Intravascular (IVUS), Transthoracic (TTE), Trans-esophageal (TEE), and Intra-cardiac (ICE) procedures
  • Faxitron: Bench-top x-ray enables high resolution imaging of specimens and devices ex vivo
  • Scanning Electron Microscopy (SEM)

Therapeutic areas and technical acumen

  • Interventional cardiology
  • Cardiovascular surgery
  • Structural heart therapies
  • Dermal
  • Electrophysiology
  • Gastrointestinal / bariatric
  • Plastic & reconstructive surgery
  • Laparoscopic / endoscopic procedures
  • Neurological
  • Oncology
  • Opthalmology
  • Orthopedic
  • Regenerative medicine
  • Respiratory
  • Urogenital
  • Women’s health
  • Wound healing
  • Hemostasis
  • Hernia repair
  • Tendon repair
  • General surgery / surgical wounds
  • Adhesion models

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