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About Us

We are Secret Codea fast-growing lead provider of consulting, and operation services in cyber risk and cloud defensive operations. Our experts operate in more than just a few countries around the world, helping businesses and organizations to learn and create a barrier to protect their own digital and monetarily data in the most complex threats in the digital Jungle of Cyber cloud security.

Our Motto: Providing personal service to each customer, suitable for the organization's needs. We mitigate the risks of cyber-attacks. We work with small /medium-sized businesses, as well as corporates and enterprises. who look for the best cost-effective solutions. We help business management protect their business assets in the safest and most secure way.

FDA Medical Classification Check List

FDA – Software Classification Checklist (CDS / SaMD / Non-Device)

FDA Software Classification

Fill out this questionnaire for a single software function to get a preliminary classification.

Step 1 – Clinical intent

1. Is the function intended for prevention, diagnosis, treatment, or monitoring of a medical condition for a specific patient?

"No" = admin, workflow, analytics, wellness, etc.

Step 2 – Non-Device CDS criteria

2. Does the function acquire, process, or analyze medical images or raw signals (CT, MRI, EEG, ECG waveforms, etc.)?

If yes → typically SaMD / medical device.

3. Does it operate only on processed medical information (diagnoses, visit summaries, lab results, EMR data, guidelines) and not on raw signals/images?

Uses reports/results, not raw sensor data.

4. Does it provide recommendations or support to an HCP, while the HCP remains the final decision-maker (no autonomous clinical decision or automatic treatment)?

Autonomous diagnosis/treatment → device.

5. Can the HCP independently understand and review the basis for the recommendations (data used, rules/guidelines), without blindly relying on the system?

Transparency is key for Non-Device CDS.

Step 3 – Device type (if Device)

6. If the function is a medical device, is its primary purpose to provide clinical recommendations to an HCP (e.g., “recommended therapy is X”) rather than automatically performing a therapeutic action?

Yes = Device CDS; No = other SaMD.

Recreating Cybercloud Safeguarding Today

Mar 28, 2011

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