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Single Fault Safety Requirements in the MDR


Medical devices are among the most highly regulated products in the world today. A single functional failure can mean the difference between life and death for patients.

In our live webinar, you will learn the need and requirements for single fault safety. Key points that will be covered:

  • Understand the need for single fault safety
  • Understand the requirements for single fault safety
  • Learn what’s on the agenda of international standardization regarding single-fault-safety
  • Learn how to achieve functional safety
  • Understand the link to IEC 62304

Andreas Purde

About the Presenter

Dr. Andreas Purde
Director PS-MHS-RBL-1

Andreas studied electrical engineering and joined TÜV SÜD 14 years ago. He now leads the unit of active medical devices in Germany.

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Middle East and Africa