| Process Area | Clause | Requirement Name | Class A | Class B | Class C | | :--- | :--- | :--- | :--- | :--- | :--- | | | 4.1 | Software Development Plan | Required | Required | Required | | Documentation | 5.1 | Software Requirements Specification (SRS) | Required | Required | Required | | Architecture | 5.2 | Software Architectural Design | Required | Required | Required | | Architecture | 5.3 | Software Detailed Design | Not Required | Required | Required | | Implementation | 5.4 | Implementation (Source Code) | Required | Required | Required | | V&V | 5.5 | Unit Testing | Not Required | Required | Required | | V&V | 5.6 | Integration Testing | Required | Required | Required | | V&V | 5.7 | System Testing | Required | Required | Required | | Release | 5.8 | Software Release | Required | Required | Required | | Maintenance | 6.1 | Maintenance Plan | Required | Required | Required | | Config Mgmt | 8.1 | Configuration Management Plan | Required | Required | Required | 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. Tab 1: Quality Management & Planning (Clause 4) | ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | Q1 | 4.1 | Has a Software Development Plan (SDP) been established? | Must define the life cycle model, deliverables, and traceability requirements. | SDP Document | | Q2 | 4.1 | Is a risk management process defined? | Must align with ISO 14971. | Risk Management Plan | | Q3 | 4.2 | Have the development standards been defined? | Define coding standards, comments, and naming conventions. | Coding Guidelines Doc | | Q4 | 4.3 | Has the Software Safety Class been determined? | Document the rationale for the classification. | Classification Report | Tab 2: Software Development Processes (Clause 5) | ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | Analysis | | | | | | D1 | 5.1.1 | Are input requirements defined? | Capture functional, interface, and performance requirements. | SRS Document | | D2 | 5.1.2 | Are requirements traceable? | Each requirement needs a unique ID. | Traceability Matrix | | D3 | 5.1.3 | Is the content of the SRS complete? | Must include functional, safety, security, and user interface requirements. | Approved SRS | | Design | | | | | | D4 | 5.2 | Has the software architecture been documented? | Define system components, interfaces, and data flows. | Architecture Diagrams | | D5 | 5.3.1 | Has the software detailed design been developed? (Class B/C) | Refine architecture to the unit level. | Detailed Design Docs | | D6 | 5.3.4 | Is there a correspondence between requirements and design? | Verify that every requirement is covered by the design. | Traceability Matrix | | Implementation | | | | | | D7 | 5.4 | Is source code implemented according to design? | Developers must follow coding standards defined in Q2. | Source Code Repo | | D8 | 5.4.2 | Are contributions to the architecture/design recorded? | If coding reveals a design flaw, update the design docs. | Change Request | | Testing | | | | | | D9 | 5.5 | Are Unit Tests defined and executed? (Class B/C) | Test each software unit (function/class) in isolation. | Unit Test Reports | | D10 | 5.6 | Is Integration Testing performed? | Verify interfaces between units/modules. | Integration Test Report | | D11 | 5.7 | Is System Testing performed? | Test against the SRS requirements in the target environment. | System Test Report | | D12 | 5.7.4 | Are regression tests performed after changes? | Ensure changes did not break existing functionality. | Regression Test Report | Tab 3: Software Maintenance & Configuration (Clauses 6 & 8) | ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | M1 | 6.1 | Is there a process for receiving feedback? | How are post-market issues fed back into dev? | Complaint Handling SOP | | M2 | 6.2 | Are problem reports analyzed? | Assess impact on safety and determine classification. | Problem Report Analysis | | C1 | 8.1 | Is a Configuration Management Plan in place? | How is version control, branching, and merging handled? | CM Plan | | C2 | 8.2 | Are change records maintained? | Who made the change, when, and why? | Version Control Logs | | C3 | 8.3 | Is configuration status accounting performed? | Can you identify the exact configuration of any released version? | Release Manifests | 5. Step 4: Traceability Matrix Structure 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. Malluvillain Malayalam Movies Upd Hot Download Isaimini [RECOMMENDED]
| Class | Definition (Risk of Injury to Patient/Operator) | Documentation Requirement | | :--- | :--- | :--- | | | No possible injury. | Basic Documentation | | Class B | Possible non-serious injury. | Standard Documentation | | Class C | Possible serious injury or death. | Rigorous Documentation | 3. Step 2: Documentation Requirements Matrix (Class vs. Requirement) This matrix dictates which clauses are mandatory based on your classification. In your XLS, use this as a filter key. Indian2480phdtsdesiremoviesfyimkv Exclusive
IEC 62304 Compliance Checklist & Traceability Matrix Template
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. 1. Introduction & Scope 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).