Software as a Medical Device (SaMD)

In today’s digital world, medical software is moving quickly, and keeping up with regulations can feel like a never-ending effort.

If you’re developing a digital health product, algorithm, or connected platform, you’re likely asking:

• Does our software qualify as SaMD?
• What does the FDA actually expect from us?
• How do we document everything without slowing down development?
• Do I have everything I need for submission?

RCA is here to help with those questions and more. We do more than just help you, we partner with you to build a structured, compliant development process that supports both innovation and approval of your Software as a Medical Device (SaMD).

Not all software is regulated, but once your product impacts diagnosis, treatment, or patient outcomes, everything changes. Software as a Medical Device (SaMD) must meet strict global standards, including:

• IEC 62304 – the standard for software lifecycle processes
• ISO 14971 – risk management for medical devices
• FDA expectations for documentation, traceability, and validation

Unlike traditional software, SaMD requires you to:

• Prove how your software was designed
• Document how it works at every level
• Show that it performs safely in real-world conditions
• Maintain traceability from requirements to testing

And with evolving regulations—like the FDA’s shift from Computer Software Validation (CSV) to Computer Software Assurance (CSA)—the expectations continue to change. RCA helps you stay ahead of it all.