An IEC 62304 checklist in XLS format is the answer used by regulatory professionals, software engineers, and quality managers worldwide. This comprehensive guide explains everything you need to know about IEC 62304 compliance checklists, why Excel is the tool of choice, and where to find templates that actually work.
Formalize how bugs are reported, analyzed for root causes, and resolved. www.qualityfwd.com Recommended Excel Template Columns
(Classes B & C) Confirm that architectural designs define interfaces between software items and identify SOUP items.
. Slowly, the red and yellow spreadsheet began to glow with successful results. The Final Audit Iec 62304 Checklist Xls
This section interfaces directly with ISO 14971 (Medical Device Risk Management).
Use conditional formatting to turn compliant rows green and non-compliant rows red for instant visual metrics.
| Source | Description | Link | |--------|-------------|------| | | Free "bare minimum" checklists for software requirements review and software release. Offered as editable Excel/Word files | openregulatory.com | | FDAToday | Free checklists including software release and software architecture checklists; specifically notes that templates are "designed to be used as an Excel or Sheets document" | fdatoday.com | | Elsmar Cove Forum | Community-updated IEC62304_Checklist.xls containing section headers with device class applicability | elsmar.com | An IEC 62304 checklist in XLS format is
Organize your rows into these six core lifecycle processes as suggested by Qualio and Signify : 1. Software Development Planning (Clause 5.1)
Auditors (FDA, Notified Bodies) expect evidence of compliance.
Does the SDP cover development, risk management, configuration management, and maintenance? Are resources, responsibilities, and timelines defined? 2. Software Requirements Analysis (Clause 5.2) Are functional and capabilities requirements documented? The Final Audit This section interfaces directly with
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
Focuses heavily on planning, requirements, system testing, configuration management, and bug resolution. Architectural design, detailed design, and formal integration testing are generally omitted.
Columns (place in row 1):
If you are developing medical device software, you have likely encountered IEC 62304 — the internationally recognised standard that defines the software life cycle processes for medical devices. Whether you are navigating your first regulatory submission or preparing for an audit, one question inevitably arises: how do you track compliance efficiently?
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