Are interfaces between software items and external components documented? Applicability: Classes B, C only. Is the design refined down to individual Software Units? Applicability: Class C only. 5.5 Software Unit Implementation and Verification: Are coding standards established and followed?
5, 5.2, "Software requirements specification (SRS)", Requirements, "Document functional and non-functional S/W requirements traceable to system requirements", "SRS document, trace matrix", "All requirements uniquely identified and testable", Not Started, Systems Engineer, , , High,
Checks that code complies with coding standards and passes unit verification (e.g., code reviews or static analysis).
: Outlining the roadmap for design and coding.
This is the largest section of the checklist. It outlines the development lifecycle from planning to release. Is there a documented Software Development Plan (SDP)? Iec 62304 Checklist Xls
24, 11.2, "Libraries and third-party components", Tools, "Control and document use of 3rd-party software, open-source, and libraries", "Bill of materials, license records, vulnerability assessment", "Third-party components evaluated and accepted", Not Started, Dev Team, , , Medium,
4, 5.1, "Software development plan", Planning, "Create plan covering scope, lifecycle model, verification/validation, configuration management, risk management", "Software Development Plan (SDP)", "Plan reviewed and baseline established", Not Started, Project Manager, , , High,
An IEC 62304 checklist XLS is a spreadsheet-based tool that provides a comprehensive checklist of requirements and activities for medical device software development, verification, and validation. The checklist is based on the IEC 62304 standard and provides a detailed and structured approach to ensure compliance with the standard.
2, 4.2, "Assign roles and responsibilities", Management, "Document responsibilities for software lifecycle activities", "Organizational chart, RACI, role descriptions", "Roles assigned and communicated", Not Started, Project Manager, , , Low, Applicability: Class C only
The checklist also proved invaluable during the Software Configuration Management and Software Problem Resolution processes. It provided a structured way to track changes, manage versions, and document the resolution of any issues that arose during development.
Find pre-built compliance tools on platforms like Greenlight Guru or Ketryx .
Maria had worked with IEC 62304 before, but she knew that it was a complex and detailed standard. To help her team stay on track, she decided to create a checklist in Excel (which she dubbed "IEC 62304 Checklist XLS") to ensure that they covered all the necessary requirements.
Go through each row with your engineering lead. If a deliverable doesn't exist, flag the status column as "Not Started" to create a live compliance roadmap. : Outlining the roadmap for design and coding
A acts as a traceability matrix and compliance tracking tool that maps the requirements of the IEC 62304 standard to your specific software project deliverables. It serves as:
This process establishes control over the source code, development environment, and release media.
Are internal teams and external users notified if a defect impacts safety? Applicability: Classes A, B, C.
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