SaMD Compliance Scorecard

Is your SaMD development
audit-ready?

Answer 15 quick questions about your software development process. We'll score you against IEC 62304 and show exactly where your gaps are, before an auditor does.

Your current development process

Select the answer that best describes where you are today. Honest answers give the most useful results.

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QMS Foundation

Does your organization have a Quality Management System (QMS) compliant with ISO 13485 or QMSR (for US-based companies)?

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Software Planning & Classification

Have you formally classified your software by IEC 62304 safety class (A, B, or C)?

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Do you have a documented Software Development Plan (SDP)?

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Where are you in your regulatory journey?

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Requirements & Traceability

Where do you manage software requirements?

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Based on your software classification, have your design outputs (architecture and detailed design) been formally documented?

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Do your software requirements trace to design outputs (e.g., architecture, detailed design)?

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Change Control & Configuration Management

How do you plan to or currently manage software changes?

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Do you maintain a formal Configuration Management Plan (CMP)?

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Do you maintain a formal SOUP register with risk assessments?

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Verification and Risk Activities

Can you trace every software requirement to a specific test or verification activity?

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How would you describe your test plans, protocols, and results documentation?

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Is your risk management integrated with software development, or managed separately?

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SW Maintenance & Problem Resolution

Do you have a documented Software Maintenance Plan?

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How do you handle software bugs and anomalies?

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Your IEC 62304 readiness score

Answer questions to see your score

Your results update live as you answer.

QMS Foundation

Planning & Classification

Requirements & Traceability

Change Control

Verification & Risk

SW Maintenance & Problem Resolution

Compliance Gaps Detected

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Scores are based on self-reported answers mapped to IEC 62304 clause requirements. This tool is for educational purposes and does not constitute a formal compliance audit or legal advice.

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Results update as you go

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Is your SaMD developmentaudit-ready?

Your current development process

Your IEC 62304 readiness score

Compliance Gaps Detected

Is your SaMD development
audit-ready?