IEC 62304 Gap Scorecard — Greenlight Guru

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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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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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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Your current development process

Compliance Gaps Detected

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