About 70% of all software-related FDA recalls are due to lack of usability. As a result, laws in Europe and the U.S. require that you identify and manage the risks posed by your products' lack of usability.

When implementing IEC 62366, manufacturers often encounter the following issues:

  • How can we succeed in meeting the legal requirements without unnecessary effort?
  • How to "specify" the usability and document this?
  • How to implement the interaction of IEC 62366 and ISO 14971 in practice?
  • How to write a verification and validation plan? What are suitable test criteria?

We will help you create a usability file that will enable you to meet the requirements of IEC 62366 and the FDA. In addition, with our usability and requirements engineers, you will quickly specify products that truly deserve the attributes of innovative and fit for use. Save yourself time and costs for unnecessary iterations and hassles in the audit.

Usability: Legal requirements

The Medical Device Directive MDD, and with it the usability requirement for medical devices, specifies that manufacturers minimize the risks posed by lack of usability. 

Interplay of laws and IEC 62366

Medical device manufacturers can presume, as part of an conformity assessment (auditors, notified bodies), that they meet specified requirements if they develop their medical devices to conform to IEC 62366. This standard is titled "Medical devices - Application of usability engineering to medical devices" in English.

Requirements of IEC 62366

The standard primarily describes a "usability engineering process". As part of this process, manufacturers must specify the usability of their "medical devices" and verify and validate the "usability". IEC 62366 imposes certain requirements on specification, verification and validation. For example, validation requires observing representative users in a representative use environment performing typical tasks on the system that are critical to our safety.

Interaction IEC 62366 and risk management according to ISO 14971

The focus of IEC 62366 is clearly on minimizing risk from lack of usability. Other goals of "usability" such as higher market success or more efficient development are not addressed

You want support in writing or checking your usability file? You want to know how fit for use your product really is? Then contact us right away!


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