Extensive Experience in the Evaluation of Medical Devices

Our medical device testing 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
• 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
• Customizable mechanical testing of both biomaterials and biological tissues
• Leaders in computational modeling of combination drug and energy delivery devices

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
• Otology
• Regenerative medicine
• Respiratory
• Urogenital
• Women’s health
• Wound healing
• Hemostasis
• Hernia repair
• Tendon repair
• General surgery / surgical wounds
• Adhesion models