Iec 62304 Checklist Xls Access

Do not just write "Done" in the status column. Use the XLS cell formatting to link directly to your Jira tickets, GitHub/GitLab pull requests, or Greenlight/Matrix Requirements documentation.

Identifying configuration items, version control, change control, and configuration audits. Problem Resolution

You might ask: Why not use expensive ALM tools? While tools like Jira or Polarion are powerful, an Excel checklist remains the industry standard for small to mid-sized companies for three reasons:

: Focuses primarily on high-level requirements, system testing, and configuration management. Detailed design (5.4) and unit testing (5.5) can be marked as N/A . Iec 62304 Checklist Xls

Software hazard analysis, risk control implementation, and verification of mitigations. Configuration

: Identify how a software failure could lead to a physical hazard for patients or operators.

. With a few clicks, she showed how a single Requirement linked to a Risk, which linked to a Line of Code, which linked to a Passed Test. Do not just write "Done" in the status column

: A plain-language summary of what the standard requires.

This module links directly to ISO 14971 (Medical Device Risk Management).

A free-text section for recording review notes, outstanding action items, or justifications for exclusion. Problem Resolution You might ask: Why not use

Before shipping to manufacturing.

5. Software Unit Implementation and Verification (Clause 5.5) Have software units been coded according to the design? Is there evidence of code reviews? Have unit tests been performed and documented? 6. Software Integration and Testing (Clause 5.6) Have software units been integrated?

Control source code versions and manage the development environment. Software Problem Resolution (Clause 9):