Scribd
Upload
364 views

IEC62304 Template Software Development Plan V1 0

This document provides a software development plan for a project. It outlines the development process, tools, activities and responsibilities. The development process involves phases like requirements specification, design, coding, testing and configuration management. Responsibilities are defined for verifying deliverables of each phase. The document also describes problem resolution and change management procedures.

Uploaded by

劉雅淇
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
364 views

IEC62304 Template Software Development Plan V1 0

This document provides a software development plan for a project. It outlines the development process, tools, activities and responsibilities. The development process involves phases like requirements specification, design, coding, testing and configuration management. Responsibilities are defined for verifying deliverables of each phase. The document also describes problem resolution and change management procedures.

Uploaded by

劉雅淇
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 11

Page 1 / 11

Software Development Plan


for
<Project name>
Version <X.X>

<Doc. No. : xxxx-xxx-xx>


Page 2 / 11

Revision History
Date Rev. Description Prepared by Approved by
Page 3 / 11

TABLE OF CONTENTS

1 Identification 4
1.1 Document overview 4
1.2 Abbreviations and Glossary 4
1.2.1 Abbreviations 4
1.2.2 Glossary 4
1.3 References 4
1.3.1 Project References 4
1.3.2 Standard and regulatory References 4
2 Software Development 5
2.1 Software development process 5
2.1.1 Overview of process phases 5
2.1.2 End of phases reviews 5
2.1.3 Deliverables 5
2.2 Software development tools 5
2.2.1 Workstation 5
2.2.2 Requirements management and documentation 5
2.2.3 Software Design 5
2.2.4 Coding and automated tests 5
2.2.5 Configuration management 5
2.3 Software development rules and standards 5
3 Development Activities 6
3.1 Software Requirement Specifications (sub section sample) 6
3.1.1 Input data 6
3.1.2 Content 6
3.1.3 Output data 6
3.1.4 Review and acceptation criteria 6
4 Modification Procedure 6
4.1 Design Change Process 6
4.2 Planning of Design Change Meeting 6
5 Project Management and Responsibilities 7
5.1 Team – human resources 7
5.2 Documentation of Activities and responsibilities 7
6 Problems resolution 7
Page 4 / 11

1 Identification

1.1 Document overview


說明此文件的目的，內容

1.2 Abbreviations and Glossary

1.2.1 Abbreviations
請加上文件中有使用到的縮寫

1.2.2 Glossary
請加上文件中所使用到詞彙

1.3 References

1.3.1 Project References

# Document Identifier Document Title


[R1] 文件 ID 加上參考文件標題

1.3.2 Standard and regulatory References

# Document Identifier Document Title


[STD1] 標準 ID 加上參考的標準

增加參考的標準，可能包括 ISO14971，ISO 13485，IEC60601，IEC62304…等


Page 5 / 11

2 Project Organization
請將整個專案的人員以架構圖或是表格表示，包含部門，職位，人員姓名等
Page 6 / 11

3 Software Development Environment

3.1 Software development tools

3.1.1 Workstation
描述軟體發展時所使用的工作平台

3.1.2 Requirements management and documentation


描述軟體需求管理所用到的工具(例如：Word, excel, Doors…等)

3.1.3 Software Design


描述進行程式設計時所用到的工具

3.1.4 Coding and automated tests


描述進行程式撰寫與測試時所用到的工具

3.1.5 Configuration management


描述建構式管理所用到的工具

3.2 Software development rules and standards


描述軟體發展所使用到的標準及規則，例如 UML model, coding rules…等
Page 7 / 11

4 Development Activities

4.1 Software development process


根據前面軟體生命週期模型定義出在軟體發展程序中的活動
請描述軟體生命週期模型，裡面可能包含哪些活動或是步驟 : (可參考標準 IEC 62304)
• 軟體需求規格 Software requirement specification,
• 軟體架構設計和細部設計 Software architectural and detailed design,
• 軟體程式撰寫 Software coding,
• 軟體單元測試 Software unit testing,
• 軟體整合測試 Software integration testing,
• 軟體系統測試 Software system testing,
• 其他 other…

4.2 Software Requirement Specifications (sub section sample)


根據前面所寫的軟體生命週期每項 Phase 中的活動進行描述

4.2.1 Input data


列出輸入的資料文件，例如臨床資料，風險分析，設計歷史…等

4.2.2 Content
請描述在這個 Phase 主要的目的，例如在這個 SRS Phase 可能會有：
• 定義出當軟體在執行時的功能需求，特性，物理特性，環境因素…等
• 定義出安全需求，例如開發及維護的方法
• 使用者文件
• 定義最終用戶

4.2.3 Output data


列出產生的文件資料，例如 SRS…等

4.2.4 Verification method and document


產出的文件使用何種方法來進行驗證，有沒有產出任何驗證報告?

4.3 Software architectural and detailed design (sub section sample)

4.3.1 Input data


列出輸入的資料文件

4.3.2 Content
請描述在這個 Phase 主要的目的

4.3.3 Output data


列出產生的文件資料

4.3.4 Verification method and document


產出的文件使用何種方法來進行驗證，有沒有產出任何驗證報告?

4.4 Software coding (sub section sample)

4.4.1 Input data


列出輸入的資料文件
Page 8 / 11

4.4.2 Content
請描述在這個 Phase 主要的目的

4.4.3 Output data


列出產生的文件資料

4.4.4 Verification method and document


產出的文件使用何種方法來進行驗證，有沒有產出任何驗證報告?

4.5 Software unit testing (sub section sample)

4.5.1 Input data


列出輸入的資料文件

4.5.2 Content
請描述在這個 Phase 主要的目的

4.5.3 Output data


列出產生的文件資料

4.5.4 Verification method and document


產出的文件使用何種方法來進行驗證，有沒有產出任何驗證報告?

4.6 Software integration testing (sub section sample)

4.6.1 Input data


列出輸入的資料文件

4.6.2 Content
請描述在這個 Phase 主要的目的

4.6.3 Output data


列出產生的文件資料

4.6.4 Verification method and document


產出的文件使用何種方法來進行驗證，有沒有產出任何驗證報告?

4.7 Software system testing (sub section sample)

4.7.1 Input data


列出輸入的資料文件

4.7.2 Content
請描述在這個 Phase 主要的目的

4.7.3 Output data


列出產生的文件資料
Page 9 / 11

4.7.4 Verification method and document


產出的文件使用何種方法來進行驗證，有沒有產出任何驗證報告?
Page 10 / 11

5 Responsibilities

5.1 Activities and responsibilities


請描述每項 Phase 如何去做驗證的動作以及驗證人員為何?

Responsibility Verification
Activity Document name Approval Comment
Service/Department Report

5.2 Planning Relevant Documents

No. Document name Purpose Contents


Page 11 / 11

6 Problems resolution
軟體疑難排解程序是一個為分析和解決問題（包括不合格品）的程序，不論他們的屬性或來源，
包括在開發、維護或其它程式執行過程中所發現的問題。

可以 reference 到 Change Management 與 Risk Management….等

You might also like