IEC 62304 gap assessment & readiness scorecard

A free tool for medical device software teams. Answer 10 questions across safety classification, verification traceability, and V&V plans. Get an instant readiness scorecard and a prioritized remediation checklist — entirely in your browser, no account, no email required.

Run the assessment

Engineering self-assessment diagnostic only. Not formal regulatory counsel, not an FDA or notified-body submission, not a 510(k)/PMA clearance guarantee, not a legal opinion. Results depend entirely on the accuracy of self-reported inputs.

Runs entirely in your browser. Nothing you enter here — your answers or your evidence notes — is sent to any server. Only anonymous, derived counts (which family, how many items) are recorded as first-party telemetry.

Safety classification

Every software item has a documented Safety Classification (A, B, or C) derived from an ISO 14971 risk analysis — not asserted informally. IEC 62304 §4.3

Evidence location (optional — stays in your browser)

Software development (Clause 5)

A software development plan exists and names the safety class. §5.1

Evidence location (optional — stays in your browser)

Software requirements are individually identified and traceable to design elements. §5.2

Evidence location (optional — stays in your browser)

Software architecture documents the item-to-unit decomposition. §5.3

Evidence location (optional — stays in your browser)

Unit implementation and verification records exist for every Class B/C unit. §5.5

Evidence location (optional — stays in your browser)

Integration and system testing records trace back to requirements and architecture interfaces. §5.6–§5.7

Evidence location (optional — stays in your browser)

Software maintenance (Clause 6)

A software maintenance plan exists, distinct from the development plan. §6.1

Evidence location (optional — stays in your browser)

Software risk management (Clause 7)

Risk control measures implemented in software are traceable to ISO 14971 records. §7.2

Evidence location (optional — stays in your browser)

Software configuration management (Clause 8)

Configuration items — including third-party and SOUP components — are uniquely identified with enforced change control. §8.1–§8.2

Evidence location (optional — stays in your browser)

Software problem resolution (Clause 9)

Problem reports are logged, evaluated for safety impact, and traced to a verified resolution. §9.1–§9.3

Evidence location (optional — stays in your browser)