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Checklist Xls [repack] | Iec 62304
1, 4.1, "Establish software lifecycle processes", Management, "Define, document and maintain software development and maintenance processes", "Software Development Plan, Software Maintenance Plan, SOPs", "Plans approved by management; versioned", Not Started, QA Manager, , , Medium,
This section interfaces directly with ISO 14971 (Medical Device Risk Management).
This is the largest section of the checklist. It tracks the step-by-step creation of the software.
(Required for Class B & C). Verifies that requirements are translated into a clean architecture, detailing interfaces with external systems and SOUP (Software of Unknown Provenance) components. Iec 62304 Checklist Xls
Columns (place in row 1):
While enterprise Application Lifecycle Management (ALM) tools like Jira, Jama, or Polarion are vital for modern software engineering, the humble spreadsheet remains indispensable for compliance gap analysis and regulatory auditing.
Do you need assistance mapping specific clauses into this spreadsheet? (Required for Class B & C)
Navigating the complexities of medical device software development requires absolute adherence to international safety standards. At the core of this compliance ecosystem sits , the globally recognized standard for medical device software lifecycle processes. For regulatory affairs professionals, software engineers, and quality assurance managers, translating this dense standard into an actionable, daily workflow is a significant challenge.
| | Requirement | Activity | Status | | --- | --- | --- | --- | | 5.1.1 | Software development planning | Create a software development plan | | | 5.1.2 | Software design | Create a software design document | | | 5.2.1 | Risk analysis | Perform a risk analysis | | | 5.3.1 | Verification and validation planning | Create a verification and validation plan | |
: Provides detailed compliance documents, including the IEC 62304 Software Development Checklist (PDF/XLS) , which outlines processes like architectural design and system testing. Do you need assistance mapping specific clauses into
Map existing software documentation against standard requirements to identify missing artifacts.
Are all source code files, tools, and documentation uniquely identified? Is there a formal change control process in place? 6. Software Problem Resolution Process (Clause 9)
An IEC 62304 checklist in XLS format is not just a compliance tool — it is a strategic asset that saves time, prevents costly audit findings, and ensures patient safety through rigorous software development processes. Whether you choose a free community template, a commercial solution, or build your own, the key is consistent application and traceability throughout the software life cycle.
