Create a blueprint of software units and their interactions. Implementation & Verification: Coding and testing (Unit, Integration, and System testing). Software Maintenance Process (Clause 6):
Are risk control measures implemented within the software design or architecture? Are risk control measures verified for effectiveness? Applicability: Classes B, C only.
24, 11.2, "Libraries and third-party components", Tools, "Control and document use of 3rd-party software, open-source, and libraries", "Bill of materials, license records, vulnerability assessment", "Third-party components evaluated and accepted", Not Started, Dev Team, , , Medium,
Are you integrating or open-source libraries into your project?
(though both remain essential for regulatory approval). Iec 62304 Checklist Xls
Is the testing conducted in a simulated or actual target environment? 8. Software Release (Clause 5.8) Is the release process documented? Does a release note exist summarizing the configuration? IEC 62304 Classifications (A, B, C) Impact on the Checklist
Define functional, performance, and safety requirements.
: A plain-language summary of what the standard requires.
18, 8.4, "Software item traceability", Traceability, "Maintain bidirectional traceability between requirements, design, code, and tests", "Traceability matrix", "All SRS items traced to design, code, and tests", Not Started, QA, , , High, Create a blueprint of software units and their interactions
20, 9.2, "Identification of hazardous situations from software", Risk, "Document hazards contributed by software and risk acceptability", "Hazard log, FMEA/FMECA", "Hazards analyzed and mitigations assigned", Not Started, Safety Engineer, , , High,
50, 33.1, "Compliance gap analysis", Audit, "Perform gap analysis vs IEC 62304 and related standards (ISO 14971, IEC 62366, ISO 13485)", "Gap analysis report, remediation plan", "Gaps closed or tracked", Not Started, Compliance Lead, , , High,
You must have a formal system for managing bugs, defects, and anomalies found during development or post-market use.
This checklist organizes requirements by the standard's lifecycle phases. For each clause, note the applicable safety class and maintain cross-references to your procedures, documents, and records. Are risk control measures verified for effectiveness
An IEC 62304 checklist XLS is a valuable tool for ensuring compliance with the IEC 62304 standard for medical device software. By using a checklist, software developers, testers, and quality assurance personnel can ensure that all necessary steps are taken during the software development lifecycle. The checklist should include key elements such as software development lifecycle processes, software verification and validation, risk management, configuration management, and quality management. By using an IEC 62304 checklist XLS, organizations can improve compliance, increase efficiency, enhance collaboration, and provide better documentation.
Companies should begin gap analysis now, especially Class B SaMD manufacturers, who face the most significant transition impact.
Are SOUP items identified with version numbers and manufacturers? Applicability: Classes A, B, C.
Update the plan regularly, especially for Class C where standards, methods, and tools must be specified.