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Below is a structured, comprehensive IEC 62304 compliance checklist you can paste into an Excel file. Each row represents one checklist item with suggested columns for tracking status, evidence, owner, and notes. Use the "Status" column values: Not Started / In Progress / Complete / Not Applicable. Adjust or remove columns to match your project process.
Columns (place in row 1):
Checklist rows (start at row 2):
1, 4.1, "Establish software lifecycle processes", Management, "Define, document and maintain software development and maintenance processes", "Software Development Plan, Software Maintenance Plan, SOPs", "Plans approved by management; versioned", Not Started, QA Manager, , , Medium,
2, 4.2, "Assign roles and responsibilities", Management, "Document responsibilities for software lifecycle activities", "Organizational chart, RACI, role descriptions", "Roles assigned and communicated", Not Started, Project Manager, , , Low,
3, 4.3, "Software safety classification", Planning, "Classify software according to safety impact (Class A/B/C)", "Safety classification report, scoring rationale", "Classification justified per IEC 62304 definitions", Not Started, Safety Engineer, , , High,
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,
5, 5.2, "Software requirements specification (SRS)", Requirements, "Document functional and non-functional S/W requirements traceable to system requirements", "SRS document, trace matrix", "All requirements uniquely identified and testable", Not Started, Systems Engineer, , , High,
6, 5.3, "Architectural design", Design, "Define high-level architecture, interfaces, modules, data flow", "Software architecture document, UML diagrams", "Architecture supports requirements and safety classification", Not Started, Lead Architect, , , 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,
8, 5.5, "Implementation", Implementation, "Implement software according to detailed design, coding standards", "Source code repository, coding standards, code comments", "Code compiles, unit tests available", Not Started, Dev Team, , , High,
9, 6.1, "Software unit testing", Verification, "Define and execute unit tests for individual modules", "Unit test cases, automated test results", "Coverage per plan; unit tests pass", Not Started, Dev Team, , , Medium,
10, 6.2, "Software integration testing", Verification, "Test integration of modules and interfaces", "Integration test plan, test reports", "All integration test cases passed", Not Started, Test Lead, , , Medium,
11, 6.3, "Software system testing", Verification, "Verify software meets SRS in system configuration", "System test plan, executed test reports", "System tests trace to SRS and pass", Not Started, QA, , , High,
12, 6.4, "Software release testing (acceptance)", Verification, "Perform release/acceptance testing with release criteria", "Acceptance test reports, release checklist", "Release approval recorded", Not Started, Release Manager, , , High,
13, 7.1, "Software maintenance process", Maintenance, "Plan and implement maintenance activities including problem resolution and change control", "Maintenance plan, change control procedure", "Issues tracked; changes controlled", Not Started, Maintenance Lead, , , Medium,
14, 7.2, "Problem resolution and tracking", Maintenance, "Record, investigate, and resolve software anomalies", "Issue tracking system, CAPA records", "All issues logged and dispositioned", Not Started, Support Lead, , , Medium,
15, 8.1, "Configuration management plan", CM, "Establish CM for software items: baselines, versioning, build control", "CM Plan, baselined repository", "Source, deliverables, and baselines controlled", Not Started, CM Manager, , , High,
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,
17, 8.3, "Build and release procedures", CM, "Define reproducible build and release processes", "Build scripts, release checklist, environment definitions", "Builds reproducible; release artifacts archived", Not Started, Release Engineer, , , High,
18, 8.4, "Software item traceability", Traceability, "Maintain bidirectional traceability between requirements, design, code, and tests", "Traceability matrix", "All SRS items traced to design, code, and tests", Not Started, QA, , , High,
19, 9.1, "Risk management integration", Risk, "Integrate ISO 14971-based risk management with software lifecycle", "Risk management plan, risk file (hazards, mitigations, residual risk)", "Risks identified, controls implemented and verified", Not Started, Risk Manager, , , High,
20, 9.2, "Identification of hazardous situations from software", Risk, "Document hazards contributed by software and risk acceptability", "Hazard log, FMEA/FMECA", "Hazards analyzed and mitigations assigned", Not Started, Safety Engineer, , , High,
21, 9.3, "Verification of safety-related requirements", Risk, "Verify that risk control measures are implemented correctly in software", "Verification test cases, results", "Safety functions verified per requirements", Not Started, Test Lead, , , High,
22, 10.1, "Software problem resolution process (post-market)", Post-market, "Process for receiving and acting on field issues and incidents", "Post-market surveillance plan, incident handling SOP", "Incidents tracked; corrective actions implemented", Not Started, Vigilance Lead, , , High,
23, 11.1, "Software tools qualification", Tools, "Identify and qualify software tools that can introduce or detect errors", "Tool qualification records, V-model for tools", "Tools categorized and qualified where required", Not Started, Tool Owner, , , Medium,
24, 11.2, "Libraries and third-party components", Tools, "Control and document use of 3rd-party software, open-source, and libraries", "Bill of materials, license records, vulnerability assessment", "Third-party components evaluated and accepted", Not Started, Dev Team, , , Medium,
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,
26, 12.2, "Record retention", Documentation, "Define retention periods and storage for lifecycle records", "Records retention schedule", "Records retained per regulatory requirements", Not Started, QA, , , Low,
27, 13.1, "Usability and human factors consideration", Usability, "Address user interface safety aspects and use-related risks", "Usability engineering file, use scenarios, validation", "Use errors analyzed and mitigations implemented", Not Started, UX Lead, , , Medium,
28, 14.1, "Security requirements for software", Security, "Define security requirements (authentication, access control, encryption)", "Security requirements spec, threat model", "Security requirements implemented and tested", Not Started, Security Engineer, , , High,
29, 14.2, "Vulnerability management", Security, "Process to identify, track and remediate security vulnerabilities", "Vulnerability log, patch management process", "Vulnerabilities assessed and remediated", Not Started, Security Team, , , High,
30, 15.1, "Verification of requirements, design, implementation", Verification, "Plan and perform verification activities throughout lifecycle", "Verification plan and reports", "Verification coverage meets plan", Not Started, QA, , , High,
31, 16.1, "Validation of software in intended environment", Validation, "Validate final software in intended use environment including clinical workflow", "Validation protocol, validation report", "Validation shows software meets user needs and intended use", Not Started, Validation Lead, , , High,
32, 16.2, "Acceptance criteria for validation", Validation, "Define measurable acceptance criteria for validation", "Validation acceptance criteria in protocol", "Criteria met and documented", Not Started, Validation Lead, , , High,
33, 17.1, "Supplier management", Supplier, "Assess and control suppliers for software components or services", "Supplier assessments, contracts, quality agreements", "Suppliers qualified and monitored", Not Started, Procurement, , , Medium,
34, 18.1, "Training and competency", Training, "Provide training for personnel on software lifecycle processes and tools", "Training records, competency matrix", "Personnel trained and records stored", Not Started, HR, , , Low,
35, 19.1, "Audit and internal review", Quality, "Plan and perform internal audits of software lifecycle processes", "Audit schedule, audit reports, corrective actions", "Findings closed within target", Not Started, QA Lead, , , Medium,
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,
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,
38, 21.2, "Regression testing for changes", Change Control, "Run regression tests when software changes are introduced", "Regression test suite, results", "No regressions in safety-critical functions", Not Started, Test Lead, , , High,
39, 22.1, "End-of-life planning", Maintenance, "Define software end-of-life and transition plans", "EOL policy, customer notifications plan", "EOL criteria and communication defined", Not Started, Product Manager, , , Low,
40, 23.1, "Record of decisions and rationale", Documentation, "Maintain decision logs for safety-critical design choices", "Decision log, meeting minutes", "Rationales traceable and auditable", Not Started, Project Manager, , , Medium,
41, 24.1, "Clinical evaluation inputs", Clinical, "Include clinical input where software affects clinical decisions", "Clinical evaluation report or literature review", "Clinical risks assessed", Not Started, Clinical Lead, , , High,
42, 25.1, "Software release notes and labeling", Release, "Prepare release notes, user manuals, labeling reflecting changes and safety information", "Release notes, instructions for use", "Documentation updated and reviewed", Not Started, Technical Writer, , , Medium,
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, Iec 62304 Checklist Xls
44, 27.1, "Logging and monitoring", Operations, "Ensure adequate logging for safety events, performance, and security", "Logging policy, logs retention", "Logs available for investigation", Not Started, DevOps, , , Medium,
45, 28.1, "Performance and reliability requirements", Non-functional, "Define and verify performance, timing, and reliability requirements", "Performance test plan, results", "Meets performance acceptance criteria", Not Started, Performance Engineer, , , Medium,
46, 29.1, "Internationalization / localization considerations", Non-functional, "Address language/regulatory variations if applicable", "Localization plan, translated documents", "Localized versions validated", Not Applicable, Product Manager, , , Low,
47, 30.1, "Device-specific software considerations", Product, "Document any device/platform dependencies and constraints", "Platform compatibility matrix", "Compatibility tested and documented", Not Started, Engineering, , , Medium,
48, 31.1, "Traceability to system-level risk controls", Risk, "Ensure software contributes to and verifies system-level risk controls", "Trace matrix linking system risk controls to software functions", "All system risk controls implemented or noted as N/A", Not Started, Safety Engineer, , , High,
49, 32.1, "Evidence of management review", Management, "Periodic management reviews of software lifecycle status", "Management review minutes, action items", "Reviews performed per schedule", Not Started, QA Manager, , , Low,
50, 33.1, "Compliance gap analysis", Audit, "Perform gap analysis vs IEC 62304 and related standards (ISO 14971, IEC 62366, ISO 13485)", "Gap analysis report, remediation plan", "Gaps closed or tracked", Not Started, Compliance Lead, , , High,
Instructions for Excel formatting:
Optional additional sheets:
Use this checklist as a complete starting point; remove or adapt items not applicable to your product.
Deep in the heart of a bustling tech hub, a small medical device startup named VitalPath was on the verge of a breakthrough. Their innovative software, designed to monitor cardiac health in real-time, had the potential to save countless lives. But there was one major hurdle standing between them and the market: regulatory compliance.
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.
Enter Sarah, a seasoned regulatory affairs specialist with a knack for bringing order to chaos. She had seen many startups stumble at this very stage, and she knew exactly what VitalPath needed: a comprehensive IEC 62304 Checklist Xls.
The spreadsheet was Sarah's secret weapon. It wasn’t just a simple list of tasks; it was a roadmap, a meticulously crafted guide that translated the dense language of the standard into actionable steps.
The first tab of the "IEC 62304 Checklist Xls" focused on Software Development Planning. It laid out the requirements for establishing a software development plan, defining the software safety classes, and identifying the necessary resources. Elias and his team began filling it out, their initial apprehension giving way to a sense of clarity.
As they moved through the subsequent tabs—Software Requirements Analysis, Software Architectural Design, Software Unit Testing, and Software Integration Testing—the checklist acted as a steady hand. It ensured that every requirement was addressed, every design decision documented, and every test case accounted for.
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.
The checklist also proved invaluable during the Software Configuration Management and Software Problem Resolution processes. It provided a structured way to track changes, manage versions, and document the resolution of any issues that arose during development.
Months of hard work culminated in a comprehensive technical file, anchored by the completed IEC 62304 Checklist Xls. When the regulatory auditors finally arrived, they were impressed by the level of detail and the clear demonstration of compliance. The checklist had transformed a daunting regulatory requirement into a manageable and even empowering process.
VitalPath’s cardiac monitor received its certification, and soon, it was being used in hospitals around the world. Elias and his team knew that their success wasn't just due to their technical brilliance, but also to the humble spreadsheet that had guided them through the complexities of IEC 62304.
Years later, Sarah would often share the story of VitalPath with other startups. She’d remind them that while the path to regulatory compliance may be challenging, with the right tools and a clear roadmap, even the most ambitious dreams can become a reality. And at the heart of that roadmap, more often than not, was a well-crafted checklist. To help you build your own IEC 62304 compliance framework , let me know: Are you aiming for Software Safety Class A, B, or C Do you need specific column headers
for the XLS (e.g., Clause #, Requirement, Evidence, Status)? Are you integrating this with a Risk Management process (ISO 14971)? I can provide a detailed breakdown of the sections you should include in your spreadsheet.
Introduction
IEC 62304 is an international standard for medical device software, which provides a framework for ensuring the safety and effectiveness of software used in medical devices. The standard outlines the requirements for the development, deployment, and maintenance of medical device software. A checklist in XLS format can be a useful tool for ensuring compliance with the standard.
IEC 62304 Checklist XLS: What is it?
An IEC 62304 checklist XLS is a spreadsheet-based tool that provides a comprehensive checklist of requirements and activities for medical device software development, verification, and validation. The checklist is based on the IEC 62304 standard and provides a detailed and structured approach to ensure compliance with the standard.
Benefits of Using an IEC 62304 Checklist XLS
Using an IEC 62304 checklist XLS can provide several benefits, including:
IEC 62304 Checklist XLS Structure
A typical IEC 62304 checklist XLS may include the following sections:
Example of an IEC 62304 Checklist XLS
Here is an example of what an IEC 62304 checklist XLS might look like:
| Clause | Requirement | Activity | Status | | --- | --- | --- | --- | | 5.1.1 | Software development planning | Create a software development plan | | | 5.1.2 | Software design | Create a software design document | | | 5.2.1 | Risk analysis | Perform a risk analysis | | | 5.3.1 | Verification and validation planning | Create a verification and validation plan | |
Conclusion
An IEC 62304 checklist XLS is a valuable tool for ensuring compliance with the IEC 62304 standard for medical device software. By using a checklist, developers can ensure that all requirements and activities are addressed, reducing the risk of non-compliance and improving the safety and effectiveness of their software. The checklist provides a structured approach to software development, verification, and validation, and can help streamline audits and assessments.
An IEC 62304 Checklist is an essential tool for medical device software teams to track compliance with the international standard for software life cycle processes. While many teams start with an Excel (.xls) spreadsheet for its ease of use, modern regulatory expectations often require more robust traceability. Core Compliance Checklist Categories
A comprehensive checklist is typically organized by the major clauses of the standard (Clauses 5–9): Software Development Process (Clause 5):
Development Planning: Establish a plan including life cycle activities and documentation.
Requirements Analysis: Define functional, performance, and safety requirements.
Architecture & Detailed Design: Create diagrams for subsystems and, for Class C, complete detailed designs.
Verification: Perform unit verification, integration testing, and system testing.
Software Maintenance (Clause 6): Establish procedures for evaluating problem reports and assessing the impact of changes on safety.
Risk Management (Clause 7): Perform software-specific hazard analysis and implement risk control measures.
Configuration Management (Clause 8): Identify configuration items (source code, SOUP, specifications) and establish baselines.
Problem Resolution (Clause 9): Document a process for investigating and resolving anomalies. Software Safety Classifications IEC 62304 Checklist (Excel-ready) — Complete Content Below
An IEC 62304 Checklist tracks compliance across the software development lifecycle for medical devices. To build an effective XLS tool, you must categorize requirements by Software Safety Class (A, B, or C) to determine which activities are mandatory. 🛠️ Core XLS Structure
Organize your spreadsheet with these headers for clear traceability: Clause ID: The specific standard section (e.g., 5.1.1). Requirement Description: Brief summary of the mandate.
Safety Class Applicability: Mark if required for Class A, B, or C.
Compliance Status: Dropdown for "Compliant," "Non-Compliant," or "N/A."
Evidence/Link: Path to the specific document or code artifact. Owner: Team member responsible for the deliverable. 📋 Key Checklist Categories 1. Software Development Process (Clause 5)
Development Planning: Define milestones and development environment.
Requirements Analysis: Document functional and performance needs.
Architectural Design: Map out software items and interfaces.
Detailed Design: Specific to Class B and C; unit-level specs.
Unit Verification: Confirmation that units meet design specs.
Integration & Testing: Verified interaction between software items.
System Testing: Testing against the final software requirements. Release: Criteria for software versioning and distribution. 2. Risk Management (Clause 7)
Hazard Identification: Software contributing to system hazards.
Risk Control: Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9)
Configuration Management: Track versions and SOUP (Software of Unknown Provenance).
Change Control: Process for approving and implementing updates.
Bug Tracking: Documented workflow for identifying and fixing defects. 🔗 Useful Resources
Templates: Find pre-built compliance tools on platforms like Greenlight Guru or Ketryx.
Integration: Check how this aligns with quality systems on I3CGlobal.
📍 Key Point: Class A devices have fewer requirements; always verify your device's safety class before finalizing the checklist to avoid unnecessary work. If you'd like, I can:
Draft a specific section of the checklist (e.g., Clause 5: Development). Explain SOUP management in more detail for your XLS. Compare requirements between Class B and Class C.
What are the IEC 62304 Safety Classifications? - Greenlight Guru
The Medical Device Software Conundrum
Dr. Maria Rodriguez, a seasoned medical device software engineer, had just been assigned to lead a project to develop a new software-controlled infusion pump. The pump would be used to deliver precise amounts of medication to patients in hospitals and clinics.
As she began to plan the project, Maria knew that she had to ensure that the software met the rigorous requirements of the medical device industry. Specifically, she had to comply with the IEC 62304 standard, which defined the lifecycle requirements for the development of medical device software.
Maria had worked with IEC 62304 before, but she knew that it was a complex and detailed standard. To help her team stay on track, she decided to create a checklist in Excel (which she dubbed "IEC 62304 Checklist XLS") to ensure that they covered all the necessary requirements.
The checklist was a comprehensive spreadsheet that outlined all the IEC 62304 requirements, including:
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.
As they progressed through the project, the checklist helped Maria's team to:
Thanks to the IEC 62304 Checklist XLS, Maria's team was able to deliver a high-quality software-controlled infusion pump that met all the relevant regulatory requirements. The pump was a success, and patients began to benefit from its precise and safe delivery of medication.
Example contents of the IEC 62304 Checklist XLS:
Here's an example of what the checklist might look like:
| Requirement | Description | Done | | --- | --- | --- | | 5.1.1 | Software development lifecycle processes | | | 5.1.2 | Software planning | | | 5.2.1 | Requirements analysis | | | 5.2.2 | Requirements validation | | | 6.1.1 | Design | | | 6.1.2 | Design verification | | | ... | ... | ... |
This is just a small sample of the many requirements and activities that are included in the IEC 62304 standard. The checklist would be much longer and more detailed, covering all the necessary requirements and activities for the software development lifecycle.
An IEC 62304 Checklist in Excel format is a tool used by medical device software developers to ensure compliance with the IEC 62304:2006 (and Amendment 1:2015) standard. It typically maps specific standard requirements to project activities and documentation, categorized by software safety classes (A, B, and C). Core Content for an IEC 62304 Checklist
A useful checklist should cover the following primary and supporting lifecycle processes defined by the standard:
Software Development Process (Section 5): Planning, requirements analysis, architectural design, detailed design, unit implementation, integration, system testing, and release.
Software Maintenance Process (Section 6): Establishing a maintenance plan and managing problem/modification analysis.
Software Risk Management (Section 7): Analysis of software contributing to hazardous situations and risk control measures.
Software Configuration Management (Section 8): Configuration identification, change control, and status accounting.
Software Problem Resolution (Section 9): Documenting, evaluating, and resolving software problems. Useful Resources & Downloads
Several platforms provide downloadable templates and detailed checklists:
Template: IEC 62304:2006 Mapping of Requirements to Documents
To create an effective IEC 62304 Checklist XLS, your spreadsheet should be structured around the standard's primary software lifecycle processes. The following text provides a comprehensive breakdown of the essential columns and rows required to satisfy regulatory auditors from Scilife and Ketryx. Recommended XLS Column Headers
Clause ID: The specific section of the IEC 62304 standard (e.g., Clause 5.1). ID Clause Requirement / Checklist Item Category Objective
Requirement/Activity: A brief description of the compliance task.
Safety Class Applicability: Indicates if the task is required for Class A, B, or C software.
Compliance Status: (Dropdown: Pass, Fail, N/A, In Progress).
Evidence Location: Link to the specific document (e.g., SDP, SRS, V&V Report).
Responsible Person: The team member assigned to verify the activity. Key Rows for the Checklist
Organize your rows into these six core lifecycle processes as suggested by Qualio and Signify: 1. Software Development Planning (Clause 5.1)
Establish Software Safety Classification (A, B, or C) with documented rationale.
Create a Software Development Plan (SDP) covering all lifecycle activities.
Define roles, responsibilities, and external system interfaces. 2. Software Requirements Analysis (Clause 5.2)
Ensure traceability exists between system-level requirements and software requirements.
Identify and document any requirements that function as risk control measures. Confirm all requirements are clear, testable, and complete. Writing Software Requirements Based on the IEC 62304
Once upon a time in the bustling hub of a medical tech startup, a lead developer named
sat staring at a complex piece of software. Her team had built a revolutionary diagnostic tool, but they faced a daunting mountain: IEC 62304 compliance
The technical jargon of "Software Lifecycle Processes" felt like a maze. To find her way through, Sarah decided to create a master IEC 62304 Checklist in Excel
. Here is how that checklist turned their chaotic "crunch time" into a smooth path to certification. The Foundation: Software Safety Classification
Sarah started her XLS sheet by categorizing their software. She knew that the level of rigor required depended on the potential for harm. : No injury possible. : Non-serious injury possible. : Death or serious injury possible. The Story Note
: Because Sarah’s team was building a heart monitor, they marked it as
, meaning every row in her checklist now required the highest level of documentation. Phase 1: The Development Planning
In the first tab of her Excel file, Sarah listed the "Rules of the Road." Development Plan : Does a document exist defining the milestones? System Requirements : Are the user needs translated into technical "shalls"? Traceability
: This was the most important column. Every requirement needed a unique ID that linked to a test case later on. Phase 2: Risk Management & SOUP Sarah added a bright red tab for Risk Control SOUP (Software of Unknown Provenance) : She listed every third-party library they used. Risk Analysis
: For every "What if the software crashes?" scenario, she added a column for "Mitigation." If a bug could cause a wrong reading, the checklist demanded a software unit test to prove it wouldn't happen. Phase 3: The Verification Marathon
As the product neared completion, the "Verification" tab became the team's daily dashboard. Unit Testing : Did the individual code blocks work? Integration Testing : Did the blocks work together? System Testing : Did the whole device meet the original requirements? The "Green" Moment : Every time a test passed, Sarah turned the cell
. Slowly, the red and yellow spreadsheet began to glow with successful results. The Final Audit
When the auditors arrived, they didn't see a stressed-out team hunting for files. Sarah simply opened her IEC 62304 Checklist XLS
. 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.
The auditor smiled. "This," they said, "is a lifecycle under control." Create Your Own Checklist
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?
IEC 62304 is the harmonized standard for medical device software development. Compliance requires establishing a set of processes and delivering specific documentation based on the software's Safety Classification (Class A, B, or C).
This "paper" provides the raw data structure for an IEC 62304 Checklist XLS. Users should copy the tables below into a spreadsheet, adding columns for "Status" (Not Started, In Progress, Done), "Evidence/Document Link," and "Responsible Person."
An essential part of the XLS checklist is the Traceability Matrix (RTM). A separate sheet in the Excel file should be dedicated to linking requirements to tests.
| Req ID | Requirement Description | Safety Class Impact | Design Element (Class/Module) | Code File Name | Unit Test ID | System Test ID | Status |
| :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- |
| REQ-001 | User Login Authentication | High (Class C) | Auth_Module | login.py | UT-Auth-01 | ST-Sec-01 | PASS |
| REQ-002 | Display Patient Vitals | Medium (Class B) | UI_Display | vitals.js | N/A | ST-UI-02 | PASS |
| REQ-003 | Log Data Export | Low (Class A) | Logger | export.py | N/A | ST-Func-03 | FAIL |
Requirements must be uniquely identifiable, testable, and traceable to Risk Management (ISO 14971).
This is where Class B and C require significantly more rigor than Class A.
This document provides the structural framework for an IEC 62304 compliance checklist. By transferring this content into a spreadsheet format, organizations can create a dynamic tool for tracking compliance, managing traceability, and preparing for regulatory audits (FDA, MDR, MHLW). Remember that the level of rigor applied to the checklist must match the Safety Classification of the software (Class A, B, or C).
Introduction: The Cost of Non-Compliance
In the world of Medical Device Software (SaMD and SiMD), the difference between market approval and a costly recall often comes down to documentation. IEC 62304 is the benchmark standard for software lifecycle processes, harmonized by regulatory bodies like the FDA (US) and notified bodies under the MDR (Europe).
However, reading the 100+ page standard is daunting. Implementing it is harder. This is where an IEC 62304 Checklist XLS becomes indispensable. An Excel spreadsheet might seem low-tech, but it is the perfect tool for gap analysis, traceability, and audit defense.
In this article, we provide a comprehensive breakdown of what a gold-standard IEC 62304 checklist must include, how to populate it, and how to use it to pass your next audit.
Note: As an AI text generator, I cannot host files, but here is exactly how to build a downloadable template or where to find a compliant one.
Option A: Build your own (Recommended for mastery)
Status (Not Started / In Progress / Complete), Verified By, Verification Date, Link to Artifact.Option B: Use template resources Search for "IEC 62304 Template Bundle" from vendors like:
Warning: Do not use a random "free download" from an unverified website. The standard was updated with Amendment 1 (2015) clarifying software system testing. Ensure your checklist references IEC 62304:2006 + AMD1:2015.
This sheet links requirements → design → code → test.
| Requirement ID | Requirement Text | Risk Control? (Y/N) | Design Element | Code Module(s) | Unit Test ID | System Test ID | Status |
| :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- |
| REQ-1 | [e.g., Device powers on] | N | ARCH-1.2 | main.c | UT-01 | ST-01 | DONE |
| REQ-2 | [e.g., Alarm triggers within 1s] | Y (Risk #12) | ARCH-3.1 | alarm.c | UT-08 | ST-11 | IN PROGRESS |
| REQ-3 | ... | ... | ... | ... | ... | ... | ... |