Pre-Clinical Affairs

iStock 000009534994XSmallThe purpose of the pre-clinical studies, which are an important step in the product development process, is to produce a comprehensive set of data regarding the safety and efficacy of the device or procedure. These tests should support the regulatory requirements as well as to provide a rationale basis for the clinical development plan selected for the product.

Dr. Chen-Zion combines her regulatory and scientific knowledge to prepare specialized pre-clinical programs which consider each product's unique properties. She designs pre-clinical plans which significantly strengthen and shorten the time to regulatory submissions (IDE, CTA, 510k etc.)

Pre-clinical services include:

  • Evaluation and assessment of pre-clinical programs
  • Design of pre-clinical studies (Bench tests, Biocompatibility, Animal models)
  • Evaluation and selection of laboratory organization(s)
  • Preparation of Study Protocols
  • Experimental project management and/or monitoring testing sites
  • Study and summary reports preparation
  • Preparation of pre-clinical sections of IDE, 510K, and PMA applications