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Sara Jaworska (Juszczyk)

Sara joined DataArt in 2023. With over eight 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.

Quality and Regulatory Affairs Senior Manager / Szczecin, Poland
Sara Jaworska (Juszczyk)
Quality and Regulatory Affairs Senior Manager
Szczecin, Poland

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From Data to Trust – Validating AI in Medical Devices with Real-World Data

February 25, 2025

From Data to Trust – Validating AI in Medical Devices with Real-World Data

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New FDA Requirements for Connected Medical Devices

October 02, 2024

New FDA Requirements for Connected Medical Devices. How Cybersecurity Impacts Regulatory Approval

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