BcomSECURE אבטחת מידע ושרותי חקירה דיגיטאלים מקצועיים ללקוחות, מפעלים, חברות, ארגונים, משרדי עורכי דין. "חברת BcomSECURE מציעה שירותי חקירות מחשב, חקירות מובייל וסמארטפון, חקירות דיגיטליות, ניתוח קבצים זדוניים, טיפול בזליגת מידע, גניבת מידע, חדירת עובדי..."

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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

Aug 3, 2011

BcomSECURE אבטחת מידע וחקירות מחשב: שרותי חקירה דיגיטאלים מקצועיים

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