Michaela Ross Hoffmeyer

As Senior Science Advisor at MRIGlobal, Michaela Hoffmeyer supports teams in in vitro diagnostic product development for government and commercial clients.

Her support includes all aspects of the diagnostic product development pipeline from R&D, through clinical validation, and all regulatory elements including FDA pre-submissions, 510(k) and de novo submissions, home-use through high complexity CLIA tests, and dual CLIA waiver submissions.

Ms. Hoffmeyer’s specialties include: in vitro diagnostic development; design control; regulated products and RUO; clinical trials and testing; laboratory Quality Management System Support.

Education

M.A., Molecular Biology, University of Texas