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Alison Sathe

Regulatory Mark
Alison founded Regulatory Mark with a vision to provide best in class regulatory services and electronic QMS software to her domestic and international partners. Serving privately held and public companies, Regulatory Mark provides regulatory and quality assurance consulting and electronic QMS solutions for medical devices and technology. Alison has a background in Biomedical Engineering and has spent her career in regulatory affairs for medical devices. Previously an executive team member overseeing Regulatory and Clinical Affairs for 100+ employee company with domestic and international sales, Alison has been regulatory lead for multiple product lines from concept and strategy through product release including regulatory submissions and FDA clearance/approval. With skill in ISO 13485 and 14971, ISO/IEC 62366, FDA 21 CFR 807 (establishment and listing), 803 (MDR), 812 (IDE), 820 (QSR) and 1040 (laser products), MDD 93/42/EEC, MDR 2017/745, MDSAP, and CMDCAS, Regulatory Mark helps clients of all sizes find the right regulatory strategies for their products and their business. 

My Speakers Sessions

Wednesday, June 5

1:00pm PDT