Lety Soto is the VP of Quality and Compliance at PathAI, where she is responsible for the Quality Assurance and Compliance programs for software products and tools, and for the biopharma lab quality. She is the original author of the PathAI Quality Management System, which is certified to 13484:2016 and MDSAP for 21CFR820. Prior to joining PathAI in 2018, Lety had led quality organizations in the medical device industry for over 20 years, specializing in software quality. She has implemented quality systems at numerous companies bringing them through to certification and has led several successful FDA inspections. Over 30 years’ experience in quality and quality systems include work on retinal imaging devices, single-use surgical instruments, spinal implants, and blood analyzers.
Lety has her SB from MIT in Mechanical Engineering.