By deploying a structured, well-formulated IEC 62304 Checklist in XLS format, medical device software manufacturers can demystify compliance requirements, lower development friction, reduce time-to-market, and guarantee the delivery of safe, reliable, life-saving software.
Rather than manually completing checklists in Word, embed the verification items into your development workflow — Jira, GitHub, or your eQMS can track compliance automatically.
Treat your checklist like code. Store it in a controlled Quality Management System (QMS) or a versioned repository (e.g., SharePoint, Git) so changes over time are auditable.
Dropdown menu (Compliant, Non-Compliant, Not Applicable).
Update the plan regularly, especially for Class C where standards, methods, and tools must be specified. Iec 62304 Checklist Xls
This document serves as a comprehensive checklist and implementation guide for IEC 62304:2006+A1:2015 (Medical device software — Software life cycle processes). It is designed to assist software developers, quality managers, and regulatory affairs professionals in establishing compliance for medical device software (SaMD). The content is structured to be easily transferable into an Excel (.xls) format, providing a framework for Software Life Cycle Process management, Safety Classification, and Deliverable Traceability.
| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | M1 | 6.1 | Is there a process for receiving feedback? | How are post-market issues fed back into dev? | Complaint Handling SOP | | M2 | 6.2 | Are problem reports analyzed? | Assess impact on safety and determine classification. | Problem Report Analysis | | C1 | 8.1 | Is a Configuration Management Plan in place? | How is version control, branching, and merging handled? | CM Plan | | C2 | 8.2 | Are change records maintained? | Who made the change, when, and why? | Version Control Logs | | C3 | 8.3 | Is configuration status accounting performed? | Can you identify the exact configuration of any released version? | Release Manifests |
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Do not just type "Done." Paste direct hyperlinks to your Jira tickets, GitHub commits, or Google Drive documentation. Store it in a controlled Quality Management System
Do you need assistance mapping specific clauses into this spreadsheet?
Test combined software units to ensure they work together.
Tailoring the XLS Template to Software Safety Classes (A, B, C)
To maximize efficiency, structure your Excel sheet with the following columns: Requirement Description Applicability (A/B/C) Status (Yes/No/NA) Evidence/Doc Link Comments/Notes Identify requirements SRS_v1.0.pdf Detail design units Only needed for B/C This document serves as a comprehensive checklist and
Third-party and open-source software must be documented, risk-assessed, and maintained. SOUP documentation is often overlooked until the audit.
: Because Sarah’s team was building a heart monitor, they marked it as
Analyze Software of Unknown Provenance (e.g., third-party libraries) for hidden risks. 4. Software Configuration Management Process (Clause 8) This tab ensures code control and repeatability.
The highest class of any component determines the class of the entire software system. Misclassification leads to either over-documentation (wasting resources) or under-documentation (compliance risk).
I can provide tailored row items or formula suggestions for your . Share public link