A comprehensive compliance checklist must cover the core chapters of the standard. Your spreadsheet should be divided into tabs or sections representing these five main processes: 1. Software Development Process (Clause 5)
This matrix dictates which clauses are mandatory based on your classification. In your XLS, use this as a filter key.
While ALM (Application Lifecycle Management) tools exist, an remains popular for several reasons:
To create your :
A summary of what the clause demands.
This section monitors the software once it is deployed in production or released to the market.
Link problem resolutions back to Clause 7 (Change Control) to prevent regressions. Tab 5: Software Maintenance Process (Clause 9) Iec 62304 Checklist Xls
Medical software requires updates, bug fixes, and patches after release. This section ensures changes do not introduce new hazards.
This process must integrate directly with ISO 14971 (medical device risk management).
37, 21.1, "Change impact analysis", Change Control, "Assess impact of changes on safety, performance, and regulatory status", "Change request, impact assessment", "Impact documented and approved", Not Started, Change Board, , , High, A comprehensive compliance checklist must cover the core
IEC 62304 Checklist XLS: The Ultimate Guide to Medical Device Software Compliance
Formalize how bugs are reported, analyzed for root causes, and resolved. www.qualityfwd.com Recommended Excel Template Columns
Your IEC 62304 XLS checklist must dynamically filter requirements based on these classes, as Class A software requires significantly less documentation than Class B or C software. Key Sections of an IEC 62304 Checklist In your XLS, use this as a filter key
This ensures that the project has a clear plan, defined development processes, and appropriate resources.