23, 11.1, "Software tools qualification", Tools, "Identify and qualify software tools that can introduce or detect errors", "Tool qualification records, V-model for tools", "Tools categorized and qualified where required", Not Started, Tool Owner, , , Medium,
Third-party and open-source software must be documented, risk-assessed, and maintained. SOUP documentation is often overlooked until the audit.
IEC 62304 categorizes software based on the severity of injury it could inflict before risk mitigation measures are applied: No injury or damage to health is possible. Class B: Non-serious injury is possible. Class C: Death or serious injury is possible. Iec 62304 Checklist Xls
38, 21.2, "Regression testing for changes", Change Control, "Run regression tests when software changes are introduced", "Regression test suite, results", "No regressions in safety-critical functions", Not Started, Test Lead, , , High,
To build a high-utility spreadsheet, format your columns to capture both the text of the standard and your internal engineering evidence. Use the following column layout for your Excel sheet: Field Name Description Clause Number The exact clause from the IEC 62304 standard (e.g., 5.1.1). B Process / Requirement Summary of what the standard mandates for that clause. C Applicability (A, B, C) 23, 11
In the realm of medical device software development, adhering to regulatory requirements and industry standards is paramount. One such crucial standard is IEC 62304, which provides a framework for ensuring the safety and effectiveness of medical device software. To facilitate compliance, many organizations utilize an IEC 62304 checklist xls, a spreadsheet-based tool that streamlines the process of meeting the standard's requirements. In this article, we will delve into the world of IEC 62304, explore the benefits of using a checklist xls, and provide guidance on how to create and utilize this valuable resource.
Are functional, performance, security, and safety requirements documented? Are user requirements traced to software requirements? Applicability: Classes A, B, C. Class B: Non-serious injury is possible
Establish processes to monitor post-market feedback and identify potential software bugs reported by users.
If you need help building out specific sections of your sheet, tell me:
Apply Clause 8 principles to post-market anomalies.
Users can filter requirements based on Software Safety Class (Class A, B, or C) to hide non-applicable clauses.