The ISO 13485 standard for Medical Devices requires design and development inputs to be:

  • Complete
  • Unambiguous
  • Able to be verified and validated, and
  • Not in conflict with each other.

But what do these characteristics mean?

Writing requirements with poor quality not only exposes you to the risk of nonconformities but can impact the safety and performance of your medical devices.

Not understanding the meaning of the ISO 13485 requirements can lead to lengthy and unnecessary discussions.

In this webinar, Peter Sebelius, a member of the TC210 who authors the ISO 13485 standard and founder of Medical Device HQ will show what the ISO 13485 requirements are on design and development inputs.

Christer Fröling, an experienced systems engineer and certified requirements expert from The REUSE Company will demonstrate how SES ENGINEERING Studio tool suite can apply AI as a means to perform requirements quality analysis on existing requirements or provide an interactive writing assistant that ensures conformity to ISO 13485 requirements characteristics in the first place. This will help you establish and maintain design and development inputs that will work well both from product development, as well as from a regulatory point-of-view. Furthermore, it helps you achieve traceability.


Tuesday, February 27, 2024, 4:00 PM CEST (Madrid)/ 7:00 AM PDT (Los Angeles)/10:00 AM EDT (Detroit)

Thursday, February 29, 2024, 9:00 AM CEST (Madrid)/ 5:00 PM JST (Tokyo)/ 7:00 PM AEDT (Sydney)

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