Developing justification documents for support of Design Inputs, Design Outputs, Design Verification Testing, Preclinical studies, and Clinical Trials.
Preclinical study design, management, and study interpretation
Supporting 510k, pre-IDE/IDE, and PMAs
Developing the scientific basis and mechanism of action messaging for new novel technologies
Training sales staff and clinicians/KOLs on mechanism-of-action of new products
Product/device/material failure investigations
Litigation support (analysis and testing, evidence review, event simulation)
Expert witness testimony for product liability and medical malpractice cases involving devices.