Sara Jaworska joined DataArt in 2023. With over 10 years of expertise in regulatory affairs and quality assurance for medical devices, she specializes in providing professional consulting services for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), including AI-driven software. Her approach emphasizes the importance of cyber security, ensuring not only that devices are secure but also that the organization's QMS incorporates systemic solutions for continuous improvement. At DataArt, her primary responsibilities include the implementation and maintenance of a comprehensive Quality Management System (QMS). She also serves as an internal auditor, ensuring that processes meet stringent industry standards and contribute to our commitment to excellence in medical device development. Sara holds a Master’s degree in Biotechnology.
Typically, software placed on the market will undergo changes and updates after its initial release. In the case of healthcare AI, changes can occur, often unexpectedly, even when the developers have not updated the model.