This is the core content for the spreadsheet. It outlines the specific activities required by the standard.
Lock the standard clause columns so team members cannot accidentally delete or edit regulatory text.
Easy to tailor to specific class A, B, or C software needs.
Is there a process for analyzing feedback and bug reports? Are patches and updates documented and verified with the same rigor as the initial release? 4. Software Risk Management Process (Clause 7)
Even with a checklist, teams frequently make these errors: Iec 62304 Checklist Xls
Utilizing a comprehensive (spreadsheet) is the most effective way to track, document, and prove compliance during audits. This article provides a deep dive into what this checklist entails, why it is essential, and how to use it to streamline your development process. What is IEC 62304 and Why Do You Need a Checklist?
A compliant checklist must mirror the three main lifecycle processes defined in IEC 62304 (Edition 1.2 / AMD 1 2015). Your XLS worksheet should have the following tabs:
Verified interaction between software items.
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, This is the core content for the spreadsheet
The team, led by a brilliant but overwhelmed software architect named Elias, knew they had to adhere to IEC 62304, the international standard for medical device software life cycle processes. They had the technical prowess, but the labyrinthine requirements of the standard felt like an impenetrable fortress.
36, 20.1, "Regulatory reporting and compliance", Regulatory, "Ensure processes for regulatory submissions and reporting", "Regulatory submission artifacts, correspondence", "Regulatory requirements addressed", Not Started, Regulatory Affairs, , , High,
Document functional, performance, and security requirements.
Offers a Requirement Mapping Template to track where each standard section is fulfilled in your documentation. Easy to tailor to specific class A, B, or C software needs
Your XLS checklist must be dynamic. If your device is Class A, you can filter out or hide rows corresponding to detailed design (Clause 5.4) and unit verification (Clause 5.5), as these are only mandatory for Classes B and C. This prevents your development team from performing unnecessary documentation work. Common Implementation Pitfalls
Map existing software documentation against standard requirements to identify missing artifacts.
43, 26.1, "Backup and restore for data integrity", Data, "Define backup and restore procedures to protect user/clinical data", "Backup SOPs, test restoration records", "Data restored successfully in test", Not Started, IT Ops, , , Medium,