Usability studies for SW only product (ISO 62366)


Involved In Discussions

We're currently in the process of developing a software-only product tailored for decision-making support. This product is specifically designed as a component for back-end/web service architecture, seamlessly integrated via API within organizational IT infrastructures. Once data is received, it operates automatically through API invocation.

The software is deployed onto and managed by middleware, accessible solely through the middleware's APIs. Importantly, the middleware does not necessitate any manipulation of input/output data.

Our software lacks a user interface and relies exclusively on machine-to-machine interaction, with no direct engagement with end users, such as healthcare professionals (HCPs).

It falls upon the customer, who implements a solution incorporating our software, to present the outputs to HCP end users using their own front-end systems. The usability aspects of these systems are the responsibility of the healthcare organization's IT professionals.

After careful consideration, we have determined that conducting usability studies is unnecessary.

Would you deem this approach reasonable?



Super Moderator
I would agree. Ensure your development plan provides this rationale for excluding 62366.
Top Bottom