Iec 62304 Checklist Xls Jun 2026

: Create a high-level architecture diagram. Identify Software Items, including Software of Unknown Provenance (SOUP), and define their interfaces (Required for Class B and C).

To create an effective , your spreadsheet should be structured around the standard's primary software lifecycle processes. The following text provides a comprehensive breakdown of the essential columns and rows required to satisfy regulatory auditors from Scilife and Ketryx . Recommended XLS Column Headers

IEC 62304 applies to the development and maintenance of medical device software when the software itself is a medical device (SaMD) or when it is an embedded part of a physical medical device. Iec 62304 Checklist Xls

—maintenance no longer includes new features, only defect fixes and adaptations.

This checklist organizes requirements by the standard's lifecycle phases. For each clause, note the applicable safety class and maintain cross-references to your procedures, documents, and records. : Create a high-level architecture diagram

Identify configuration items (source code, SOUP, specifications) and establish baselines.

Disclaimer: This checklist is a guide based on IEC 62304:2006/AMD 1:2015. Always consult the official standard and a regulatory expert for project-specific needs. The following text provides a comprehensive breakdown of

: A dropdown menu featuring Compliant , Partially Compliant , Non-Compliant , or Not Applicable (N/A) .