GuidanceAI/ML
2026 FDA Guidance - Clinical Decision Support Software
This FDA guidance clarifies which clinical decision support (CDS) software functions are excluded from the definition of a medical device.
Valeriia Zakrasniana
ADMIN ASSISTANT
Joined: October 30, 2024
Five years in executive assistant, operations, and marketing roles at four companies preceded Innolitics, where since October 2024 I handle statements of work and project tracking for 510(k) engagements. I run the semiannual performance review cycle, onboard new hires, and organized the 2026 team retreat, and I have supported [sensitive: 13 client accounts across 17 projects] since joining. I hold a Master of Mathematics from Kyiv National University (2025) and a bachelor's degree in marketing and PR, and I bring five years of operations and administrative experience working in English, Ukrainian, and German.
I’m a mathematician with five years of experience in operations and administrative assistance, complemented by a strong passion for organization and process optimization. My expertise lies in managing information effectively and supporting teams to achieve their goals. I am dedicated to delivering exceptional results by streamlining workflows and enhancing productivity, always striving to contribute to the success of my organization.
Cooking, Swimming, Psychology
GuidanceAI/ML
This FDA guidance clarifies which clinical decision support (CDS) software functions are excluded from the definition of a medical device.
Valeriia Zakrasniana
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Valeriia Zakrasniana
