Best practices in focus: Notified body auditors and reviewers reflect on medical software auditing and cybersecurity requirements

The rapid growth of medical software and its integration into healthcare systems has heightened the need for cybersecurity measures. The presentation aims to share experiences and insights of notified body auditors and reviewers to highlight best practices in auditing medical software. The key challenges faced during quality management system audits and technical documentation assessments are compliance with evolving cybersecurity requirements and ensuring adherence to regulatory frameworks. Furthermore, effective strategies for addressing cybersecurity risks, and streamlining documentation processes. Emphasis is on risk management, lifecycle assessments, and incorporating international standards like IEC 81001-5-1:2022. The general idea is to harmonize auditing practices, enhance cybersecurity readiness, and ensure patient safety while supporting innovation in medical software development.