Ady Banin Consulting

Ady Banin is a regulatory and quality professional in the field of medical devices with over 17 years of practical experience in leading companies in successfully meeting regulatory requirements. Ady has diverse experience with various devices, from implanted products (active and inactive) to products that use software and artificial intelligence. Ady is detail-oriented, with high analytical capabilities and a love for data analysis; has a practical, hands-on approach and creative thinking that helps solve complex situations; and a passion for learning and teaching. Ady's expertise includes (non-exhaustive list): • Setting up quality systems from scratch and managing them, including continual improvement and regulatory compliance • Customized training, tailored to the learners' needs • Risk management • Leading NB audits and FDA inspections • Managing regulatory compliance of SW and AI-based medical devices • Regulatory submissions (EU, US, Israel (AMAR)), including communication with regulatory bodies • Performing standards gap analysis • Leading sterilization processes and aseptic processing from a quality and regulatory perspective • Cleanrooms- from setup to routine, with a focus on microbial testing and monitoring of the rooms • Cleaning/disinfection processes • And more

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