//free\\ — Iec 62304 Checklist Xls

To ensure your medical device software meets regulatory standards, you can find editable IEC 62304 checklists in XLS format through several professional platforms. These checklists typically map the standard's requirements to your specific software safety class (A, B, or C). 📂 Top Sources for IEC 62304 XLS Checklists

Elsmar Quality Forum: A community-driven resource where users share and peer-review quality management templates. You can find a specific IEC 62304:2006/AMD1:2015 Checklist (.xls) file attached to their forum threads.

Scribd: Provides detailed compliance documents, including the IEC 62304 Software Development Checklist (PDF/XLS), which outlines processes like architectural design and system testing.

Standard Norge (SEPT): Offers a highly detailed SEPT IEC 62304 Checklist in Word format that can be easily converted or tailored for Excel use. It classifies physical evidence across over 325 items, including procedures and records.

OpenRegulatory: While often providing Markdown or PDF templates, they offer a Mapping of Requirements to Documents that serves as a structural foundation for creating your own XLS compliance matrix. 📋 Core Compliance Categories Iec 62304 Checklist Xls

A standard-compliant checklist should cover these key lifecycle processes:

Software Safety Classification: Determining the rigor required (Class A, B, or C).

Development Planning: Outlining the roadmap for design and coding.

Requirements & Architecture: Documenting functional needs and technical structure. To ensure your medical device software meets regulatory

SOUP Management: Tracking "Software of Unknown Provenance" (third-party libraries).

Verification & Testing: Ensuring unit and system tests meet specifications.

Release & Maintenance: Final sanity checks before deployment and post-market procedures. IEC 62304:2006/AMD1:2015 Checklist .xls file attached

Title: IEC 62304 Compliance Checklist & Traceability Matrix Template Create an Excel Workbook

Abstract This document serves as a comprehensive checklist and implementation guide for IEC 62304:2006+A1:2015 (Medical device software — Software life cycle processes). It is designed to assist software developers, quality managers, and regulatory affairs professionals in establishing compliance for medical device software (SaMD). The content is structured to be easily transferable into an Excel (.xls) format, providing a framework for Software Life Cycle Process management, Safety Classification, and Deliverable Traceability.

4. Step 3: The Master Checklist (Excel Data Structure)

This is the core content for the spreadsheet. It outlines the specific activities required by the standard.

6. Implementation Instructions

To create your IEC 62304 Checklist Xls:

  1. Create an Excel Workbook.
  2. Sheet 1: "Dashboard" – Include the Safety Classification logic and a summary of the project status.
  3. Sheet 2: "Documentation Matrix" – Copy Table 2 (Section 3) to filter requirements by Class.
  4. Sheet 3: "Audit Checklist" – Copy Tables in Section 4 (Q1–C3). Add a column for "Auditor Comments" and "Evidence Location."
  5. Sheet 4: "Traceability Matrix" – Copy Table in Section 5. This is your living document during development.
  6. Sheet 5: "Annex A Crosswalk" – Map your internal SOPs to IEC 62304 clauses.

How to use this as an XLS file

  1. Open Excel → New Workbook.
  2. Rename Sheet1 to Legend.
  3. Rename Sheet2 to Dev_Process.
  4. Rename Sheet3 to Risk_Mgmt.
  5. Rename Sheet4 to V_and_V.
  6. Rename Sheet5 to Traceability.
  7. Copy the tables above into the respective sheets.
  8. Apply conditional formatting for Status column:
    • NOT STARTED → Red fill
    • IN PROGRESS → Yellow fill
    • DONE → Green fill
    • N/A → Gray fill
  9. Freeze the top row in each sheet.

⚠️ Important: This checklist is a template. For Class C software, you must also address: