ISO 13485:2016 and the new Risk-based Approach

Questions? Request more information from our specialists


The new ISO 13485:2016 quality management system standard for medical devices introduces lots of new changes and concepts. However, its emphasis on risk management and a risk-based approach has many device companies wondering exactly what they need to do to meet the expectations of Notified Bodies. As the deadline to recertify approaches, a clear understanding of the standard's risk requirements is critical.

In this white paper, we detail the changes required by the standard along with some suggested updates in regards to the risk-based approach. We'll answer your biggest questions about risk management in ISO 13485:2016, including:

  • a summary of changes
  • requirements for processes and supplier controls, software validation, human resources, and more
  • Internal audits, CAPAs, and FSCAs
  • and much more

You'll learn all this and more in our 12-page white paper.