62304 Checklist Xls __top__ | Iec

16, 8.2, "Identification and control of baselines", CM, "Define items under configuration control and baselines", "Baseline records, change records", "Baselines approved and auditable", Not Started, CM Manager, , , High,

7, 5.4, "Detailed design", Design, "Specify module-level design to support implementation and verification", "Module design specs, data structures, algorithms", "Design complete and reviewable", Not Started, Developers, , , High,

To create your :

is an international standard that specifies life cycle requirements for medical device software. It defines processes, activities, and tasks to ensure software safety.

IEC 62304 Checklist XLS: The Ultimate Guide to Medical Device Software Compliance Iec 62304 Checklist Xls

One afternoon, a heated debate erupted in the engineering room. A new feature was being proposed, but Elias was concerned about its impact on software safety. Sarah pointed him to the "Software Risk Management" tab of the checklist. By following the prompts and documenting the potential hazards and mitigation strategies, the team was able to objectively evaluate the feature and make an informed decision.

If you are building your own XLS, ensure you include these columns for every requirement: : (e.g., REQ-001) Description : What the software must do. Safety Class : (A, B, or C) : Linking it to your Risk Management File (ISO 14971). : Where the requirement is addressed in the architecture. Test Case ID : The proof that it works. : (Open, In Progress, Verified) software versus Class C?

For a practical .xls tool, organize your spreadsheet with these headers: IEC 62304 QMS Checklist for Medical Software Teams

You must have a formal system for managing bugs, defects, and anomalies found during development or post-market use. A new feature was being proposed, but Elias

: Ensure all anomalies are evaluated before deployment. Create a clear package creation process to ensure users receive the correct version. Clause 6: Software Maintenance Process

: Project managers, software engineers, and Quality Assurance (QA) professionals can collaborate using a single, universally accessible document. 2. Core Structure of the IEC 62304 XLS Checklist

Using Excel for compliance requires discipline to avoid version control errors.

Are the development processes, resources, and lifecycle models defined? If you are building your own XLS, ensure

Utilizing an is the most practical way to manage the documentation burden required for medical device software certification. By ensuring every requirement of the standard is met, tracked, and verified, manufacturers can reduce risk, accelerate development, and ensure compliance with global regulatory standards.

The standard applies to both standalone medical software (SaMD) and software that is embedded or an integral part of a final medical device. It is referenced by the FDA, cited in EU MDR technical documentation requirements, and recognized by regulatory authorities in Canada, Japan, Australia, and most other major markets.

What (Agile, Waterfall, V-Model) do you follow?