Samuel Evans Email & Phone Number

Salt Lake County, Utah, United States

New Britain, PA

Norristown, PA

• I oversaw product development of class III medical devices – transcatheter aortic valve and delivery catheter. I developed projects from concept generation to patient use. I was involved in all pre-clinical testing in.
• Product development: TAV (multiple sizes and designs), catheter delivery systems (1st & 2nd generation), and loading devices. I have been instrumental in bringing products from concept generation to First-In-Human.
• Development of risk analysis, product specifications, device history files, and other ISO 13485 quality system documentation.
• Pre-submission meetings with FDA (face-to-face in Bethesda, MD), regulatory submission for Health Canada, and interactions with European Notified Bodies (DEKRA & BSI).
• Physician training using in-vivo animal studies and in-vitro simulators with internationally renowned interventional cardiologists and cardiothoracic surgeons, with continued collaboration for product development.
• Familiar with catheterization labs and hybrid operating suites from pre-clinical animal testing and training to First-In-Human clinical experience.

Norristown, PA

Processed patient samples in a pathology laboratory to decontaminate and prepare microscope slides to diagnose mycobacterium diseases and report critical results to physicians in a timely manner.

Gathered technical information for a chronic, GLP animal study for a left ventricular assist device. This study was conducted at the animal resource center at the University of Utah.

M.S., Biomedical Engineering

B.S., Biology