This sheet links requirements → design → code → test.
This section interfaces directly with ISO 14971 (Medical Device Risk Management).
: The team member responsible for delivering the artifact.
A robust checklist spreadsheet must be structured logically. Create columns that capture both the requirement and the evidence of fulfillment. Essential Spreadsheet Columns
Serve as a live index during a notified body or FDA audit to point inspectors directly to specific design history file (DHF) evidence.
Identify software-specific hazards and document risk control measures (must align with Software Configuration Management (Clause 8): Iec 62304 Checklist Xls
Software contributing to system hazards.
If your medical device relies on software—whether it's embedded firmware, a standalone SaMD application, or an AI-driven diagnostic tool—IEC 62304 compliance is . Yet countless device manufacturers treat compliance as a bureaucratic burden rather than an engineering advantage. The result? Failed audits, regulatory delays, reams of unnecessary documentation, and—most critically—potential safety gaps.
Using a spreadsheet-based checklist (XLS/Excel) offers several advantages over a static document:
: Ensure all anomalies are evaluated before deployment. Create a clear package creation process to ensure users receive the correct version. Clause 6: Software Maintenance Process
Once you have established your baseline checklist, consider automation to reduce manual effort: This sheet links requirements → design → code → test
The most effective approach combines a solid checklist foundation with intelligent automation, integrating compliance checks into the tools your development team already uses. Whether you start with a free template from OpenRegulatory or build a custom XLS from scratch, the key is consistency, traceability, and the discipline to verify every item before moving to the next phase.
sat staring at a complex piece of software. Her team had built a revolutionary diagnostic tool, but they faced a daunting mountain: IEC 62304 compliance
If your medical device contains software—or if your device connects to a cloud platform that performs a clinical function—the international standard IEC 62304 almost certainly applies to you. It defines the requirements for software development and maintenance life cycles, establishing a common framework for planning, developing, testing, releasing, and maintaining software throughout its entire operational life.
Specific to Class B and C; unit-level specs.
, meaning every row in her checklist now required the highest level of documentation. Phase 1: The Development Planning A robust checklist spreadsheet must be structured logically
(though both remain essential for regulatory approval).
Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9)
Structuring the Checklist Across the 5 Core Life Cycle Processes
| | Definition | Example | Required Rigor | |:---:|:---|:---|:---| | A | No injury or damage to health possible | Admin scheduling software | Minimal documentation | | B | Non-serious injury possible | Vital sign monitor with backup systems | Moderate requirements, unit testing, integration testing | | C | Death or serious injury possible | Insulin pump, ventilator control | Maximum—architectural design, comprehensive unit/integration/system testing, full traceability |