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#01 | What is this template?

This checklist helps product teams determine whether their solution qualifies as regulated Software as a Medical Device (SaMD) or remains in the consumer digital health space. By systematically working through each section, you can build clarity on your regulatory obligations, avoiding gray zones, and building a clear compliance roadmap for your prospective or existing health/medical tech solution.

This template pairs with our recent article “Understanding SaMD: Regulated Medical Device Software vs. Consumer Digital Health Products”…

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#02 | Getting started with this template

In the top navigation bar, hit “Duplicate” and add this template to a new or existing Notion template. It will then become fully editable.

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Template created by Star Global

Future-back approach with intentional execution. We anticipate clients’ long -term needs and build solutions that drive sustainable growth and lasting impact.

Interested in partnering? Contact us | Star

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#03 | Scoring Guidance

• If most answers emphasize wellness only, low risk, no PHI, stand-alone use, consumer sales, the product likely fits in the consumer health category.
• If answers show clinical purpose, higher risk, PHI handling, workflow integration, reimbursement focus, the product almost certainly qualifies as SaMD and should follow regulatory pathways.

For gray zones, teams should document their rationale and develop a regulatory strategy that anticipates future evolution into SaMD.

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Intended Purpose and Functional Scope

Risk and Patient Safety

Data Strategy and PHI Handling

Integration into Clinical Workflows

Additional Criteria

Go-to-Market & Commercial Implications