Meet the Team

Manya Harsch, MS

Manya Harsch, MS is a biostatistician at Technomics Research, LLC with over 10 years of experience in the medical device industry. She has worked at major medical device companies with emphasis on cardiac and urological devices. She is an enthusiastic, experienced critical thinker with strong statistical background and solid biological training and understanding of clinical trials.

She has extensive experience with pre-IDE, IDE and PMA submissions, Condition of Approval studies, 510K submissions, Japan PMDA submissions and supporting PMDA GCP audits.

Ms. Harsch holds a B.S. in Biology from Utah State University, an M.S. in Zoology and an M.S. in Applied Statistics from North Dakota State University.