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Medical Software: Management and validation according to ISO/TR 80002-2

This course is dedicated to the management and validation of medical software in accordance with ISO/TR 80002-2, focusing on risks, required controls, and audit expectations.

This course belongs to the “Special Processes and Technical Compliance” line.

Contact our team if you would like a complete training package covering all related topics, or to request a tailored solution.

Abstract

This course is dedicated to the management and validation of medical software in accordance with ISO/TR 80002-2, focusing on risks, required controls, and audit expectations. It provides practical tools for document verification and the integration of software into the Quality System.

Key Points

  • Medical software management and validation

  • Risk management and required controls

  • Audit expectations

  • Documentation and Quality System integration

Structure

8-hour course.

Live streaming or on-site at your company, based on your needs.

Would you like to host this course at your company?

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