IEC 62304:2006+A1:2015 — Gap Analysis
Medical Device Software — Software Lifecycle ProcessesAbout IEC 62304:2006+A1:2015
IEC 62304:2006 with Amendment 1:2015 specifies the lifecycle processes for medical device software. It applies to embedded software within medical devices and to standalone software that is itself a medical device (Software as a Medical Device, SaMD). The standard introduces safety classification (Class A: no injury possible; Class B: non-serious injury possible; Class C: death or serious injury possible) that determines depth of process rigour. It is harmonised under EU MDR/IVDR and aligned with FDA expectations.
Issuing Body
IEC Technical Committee 62A
Edition
2015
Coverage
Software lifecycle processes for medical device software (embedded or standalone — SaMD). Safety classifications A, B, C based on possible harm.
Typical Users
Medical device manufacturers developing embedded software or Software as a Medical Device (SaMD) — required by EU MDR/IVDR and harmonised with FDA expectations.
How to use this tool
1. Work through each clause. For each requirement, choose Compliant, Partial, Non-compliant, or leave as Not assessed.
2. Add notes against any requirement to record evidence, gaps, or corrective actions.
3. Click Save progress — data is stored locally in your browser, never uploaded.
4. Export the report as TXT, CSV, JSON or print to PDF for your audit file.
Note: This tool is a guided self-assessment. It does not replace a third-party audit and the authoritative version of the standard must be obtained from the issuing body.
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