: Treat your checklist as a formal quality record. Store it in your Quality Management System (QMS) and update it at major project milestones.
: The team member responsible for delivering the artifact.
Some videos on YouTube related to IEC 62304:
Maria and her team used the checklist to methodically work through each phase of the software development lifecycle. They checked off each requirement as they completed it, and used the checklist to ensure that they didn't miss any critical steps. Iec 62304 Checklist Xls
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.
Copy the official clause list into your template before your kickoff meeting.
IEC 62304 divides the software lifecycle into five distinct process groups, alongside underlying risk management and configuration tasks. Your XLS spreadsheet should feature separate tabs or clear visual sections matching these main headings. 1. Clause 5: Software Development Process : Treat your checklist as a formal quality record
The specific team member or role assigned to execute and verify the clause.
25, 12.1, "Document control", Documentation, "Ensure controlled documents: versioning, approvals, distribution", "Document register, document control procedure", "Documents current and archived", Not Started, Document Controller, , , Low,
Dictates code reviews, unit testing, and coding standard adherence. Class A is exempt; Class B requires implementation proof; Class C requires documented rigorous verification. Some videos on YouTube related to IEC 62304:
37, 21.1, "Change impact analysis", Change Control, "Assess impact of changes on safety, performance, and regulatory status", "Change request, impact assessment", "Impact documented and approved", Not Started, Change Board, , , High,
Three individual columns marking Yes (Y) or No (N) . Class A requires the least documentation, while Class C requires full adherence to all clauses.