Med Device Solutions for 2026

Kathianne (Kat) Ross is the Manager of IT Compliance at Fujirebio Diagnostics, Inc., (FDI) and is a Subject Matter Expert in FDA 21 CFR Part 11 and GAMP methodology for development and validation of GxP computerized systems. She has over 25 years of experience planning, executing, and managing all aspects of system development and validation projects for proprietary software, as well as COTS software sold commercially (as the vendor), and purchased (representing the end user).

A Customer Success Manager with Kneat, Tim completed a Bachelor of Science and established a career in Forensic Science and Chemistry, before applying his strong understanding of quality assurance and validation processes to customer facing roles within quality assurance software organizations. Tim is a Paperless Validation Subject-Matter-Expert and works closely with many of Kneat’s largest customers to ensure the success of their digitized validation programs.