What we do
Comprehensive literature review and durability evaluation strategy
Cardiovascular biomechanics for device design, testing, and marketing messaging
Preclinical, cadaver, and clinical imaging studies to acquire boundary conditions
Boundary condition and reduced durability testing rationale for regulatory submissions
Execution of FEA and benchtop testing or working with your internal resources
Partnering during the entire submission process until approval (FDA, CE, PMDA, etc.)
Biomechanical rationale for reducing clinical trial constraints, e.g., widening criteria to improve recruitment
Expert services for FDA Panels, litigation, root cause, etc.
Clinical feedback from interventionalists (surgeons, radiologists, cardiologists)
Mock pre-sub review by experts and former FDA reviewers
Nitinol processing for optimizing fatigue performance
Door-to-door professor – Seasoned teacher to uplevel your team’s biomechanics knowledge