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Design Control according to ISO 13485/MDSAP: Robust and Audit-ready design

This course provides an in-depth overview of Design Control applied to medical devices according to ISO 13485 and MDSAP requirements, focusing on structured design, traceability, and impact on technical documentation.

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 provides an in-depth overview of Design Control applied to medical devices according to ISO 13485 and MDSAP requirements, focusing on structured design, traceability, and impact on technical documentation. It offers practical guidance to make the design process robust and audit-ready.

Key Points

  • Design Control

  • Structured design and traceability

  • Technical documentation impact

  • Robust and audit-ready design

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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