Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
      • Deprecated
      • Templates
        • T-012-001 Requirements
        • T-012-003 Test run
        • T-012-004 Software version release
        • T-012-005 Design change control
        • T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
        • T-012-007 Formative evaluation plan_YYYY_nnn
        • T-012-008 Formative evaluation report_YYYY_nnn
        • T-012-009 Validation and testing of machine learning models_YYYY_nnn
        • T-012-010 Device backup verification_YYYY_nnn
        • T-012-012 Customers product version control_YYYY_nnn
        • T-012-013 Design stage review
        • T-012-014 Summative evaluation plan_YYYY_nnn
        • T-012-015 Summative evaluation report YYYY_nnn
        • T-012-016 Software usability test guide
        • T-012-017 Integration test review
        • T-012-018 Test plan
        • T-012-019 SOUP
        • T-012-020 Predetermined Change Control Plan
        • T-012-021 Product Design Phase 1 Checklist
        • T-012-022 Software Design Phase 2 Checklist
        • T-012-023 Software Development Plan
        • T-012-024 Software Candidate Release Phase 3 Checklist
        • T-012-025 Software Verification Phase 4 Checklist
        • T-012-026 Product Validation Phase 5 Checklist
        • T-012-027 Version delivery description
        • T-012-028 Software Requirement Specification
        • T-012-029 Software Architecture Description
        • T-012-030 Software Configuration Management Plan
        • T-012-031 Product Requirements Specification
        • T-012-032 SOUP Name
        • T-012-033 Software Tests Plan
        • T-012-034 Software Test Description
        • T-012-035 Software Test Run
        • T-012-036 Software development plan
      • Specific procedures
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-012 Design, Redesign and Development
  • Templates
  • T-012-036 Software development plan

T-012-036 Software development plan

Change history​

RevisionSummaryDate

Software development project plan​

Project objectives​

(No content provided in this section)

Project organization​

RoleDescription and ResponsibilitiesPerson

Security class and software risk​

Instructions

Describe Device Class and Security Class according to MDR and FDA.

Project planning​

Project management tools​

Resource identification​

Instructions

If specific resources are needed for the project such as a calibrated measurement tool or a simulator, they shall be identified, referenced and managed in configuration.

Relationships with project stakeholders​

Customer or end-user involvement​

Instructions

Describe how the customer or end-user is involved in the software development: meetings, reviews, and presentations of intermediate versions.

External human resources​

Instructions

Describe how external human resources are managed: onboarding, integration in AI LABS's team, etc...

Relationships with other teams​

Instructions

Optional Describe relationships with other teams of your company, like the team in charge of the system design.

Communication​

Meetings​

Instructions

Describe what kinds of meetings are organized during the project and what happens in these meeting. This may be described in your quality management system. In this case, this section is not applicable.

Training​

Instructions

Describe training of people involved in the project, if applicable.

Communication channels​

Instructions

Describe how personnel communicates E-mail / Instant messaging / Meetings. :::

Document version control strategy​

Instructions

Describe version control strategy see SOP01.

Activities and responsibilities​

Very important, don't skip it! Each activity has someone responsible, mandatory. For small teams, may be always the same person.

ActivityResponsibilityService/DepartmentComment
Project managementProject ManagerFoo
Configuration tools managementConfiguration ManagerBar
Setting up the Development toolsConfiguration ManagerBar
Software specificationsProduct championFoo

Software Development Activities​

::info Instructions The section lists and describes the software development activities of the PRODUCT project. :::

Development Process Phases​

Instructions

Describe Software Development Procedure Phases.

Software development tools​

Instructions

The section lists the software development tools used and describes their usage.

Workstation​

Instructions

Describe the typical Workstation used for development.

Requirements management and documentation​

::: info Instructions Describe tools used to write and manage requirements. :::

ToolUsed for
Atlassian JiraCreate and manage sprints, create/edit/manage Software Requirements, Test Cases, User stories, Tasks, Bugs

Software Design​

Instructions

Describe tools used for software design.

ToolUsed to
Visual studio codeIDE tool

Coding and Automated Tests​

Instructions

Add and describe tools used for coding and automated tests.

ToolUsed to

Configuration management​

Instructions

Add and describe tools used for configuration management and bugs management. The configuration management is described in the SF14.11 Software Configuration Management plan.

ToolUsed to
Atlassian BitbucketProvide git hosting infrastructure in the cloud

Obsolescence management​

Instructions

Describe how you manage the obsolescence of software development tools: Either you update them when a new version comes up. Or you stick to a version during the development and maintenance. Explain your choice.

Updates are made when a new version of the software development tool comes up, with the following attention points:

  • All updates are made using the official channel of the development tool.
  • Before updating any tool, developers check the compatibility with the development tool.
  • If not compatible, a message is clearly displayed, meaning it shouldn't be updated prior to a thorough investigation from the lead software engineer.
  • If compatible with the development tool, developers update all the plugins and tools.
  • This best practice guarantees they all have the latest features of these software.
  • The lead software engineer ensures all developers make the updates.
  • Note that these development tools are separated from the source code and do not affect the product.

Programming languages​

Instructions

List the programming languages used in the project.

LanguageCompiler version

Software development rules and standards​

Instructions

Describe here the standards and rules used for software development, like modelling (UML), data modelling, coding rules....

Development Methodology​

Instructions

You may describe how the team works. This part should describe how the agile.

Product Design Methodology​

Instructions

You may describe how the Product Design team works. This part should describe how the agile.

Servicing activities and maintenance​

Instructions

You may describe how AI LABS handles support and maintenance.

SOUPS, Software Items and NPS management​

Instructions

You may describe how the team handles SOUPs, Software Items identification and NPS.

Previous
T-012-035 Software Test Run
Next
Specific procedures
  • Change history
  • Software development project plan
    • Project objectives
    • Project organization
    • Security class and software risk
    • Project planning
    • Project management tools
    • Resource identification
    • Relationships with project stakeholders
      • Customer or end-user involvement
      • External human resources
      • Relationships with other teams
    • Communication
      • Meetings
      • Training
      • Communication channels
    • Document version control strategy
  • Activities and responsibilities
  • Software Development Activities
    • Development Process Phases
    • Software development tools
      • Workstation
      • Requirements management and documentation
      • Software Design
      • Coding and Automated Tests
      • Configuration management
      • Obsolescence management
      • Programming languages
      • Software development rules and standards
    • Development Methodology
    • Product Design Methodology
  • Servicing activities and maintenance
  • SOUPS, Software Items and NPS management
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)