Device makers now owe FDA a cybersecurity plan with each submission. Identity is a large part of it.

The premarket guidance asks manufacturers to describe authentication and authorization for device interfaces, including service and maintenance access. In practice that means no shared hard-coded passwords, unique credentials or certificates per device, and a way to revoke a technician's access. We design those controls and the documentation that explains them.

We build the data side. SBOMs generated in your build systems feed a store that matches components against vulnerability sources, and the results route to the product security team with device and version context. Decisions on patching and FDA reporting stay with your regulatory and quality teams.

Bot detection at the login edge and breached-password checks usually cut the volume within weeks. Passkeys take longer because customers adopt them gradually, but each enrollment removes a password that can be stuffed.

It can apply to a device company that offers software or hardware designed to maintain medical information for consumers or providers. Whether your product qualifies is a question for counsel, and we can document what health data the product stores and who can reach it.