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-012-014 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
      • 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 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-012 Design, Redesign and Development
  • Templates
  • T-012-001 Requirements

T-012-001 Requirements

Category​

  • Major
  • Minor

Source​

Instructions

Insert the name of the person(s) that suggested the creation of the requirement.

Requirement type​

  • Functional and capability
  • System inputs and outputs
  • Interfaces
  • Software-driven alarms, warnings, operator messages
  • Security
  • Usability
  • Data definition and database
  • Installation
  • Operation and maintenance
  • User documentation to be developed
  • User maintenance
  • Regulatory

Activities generated​

Instructions

Insert the code(s) of the activities generated from the requirement.

Risks controlled by the requirement​

Instructions

Insert the hazard(s) ID and description (coming from the R-TF-013-002 Risk management record) that are controlled by this requirement.

Risks caused by the requirement​

Instructions

Insert the hazard(s) ID and description (coming from the R-TF-013-002 Risk management record) associated with the implementation of this requirement.

User Requirement, Software Requirement Specification, Design Requirement and Regulatory Requirements​

  • User Requirement:
  • Software Requirement Specification:
  • Design Requirement:
  • Regulatory requirement:

Description​

Instructions

Insert the description of the requirement, including the risk control measures implemented to address the hazards and success criteria for the verification of the requirement.

References​

Instructions

Insert any references associated with this requirement (e.g. published papers).

Design change management​

info

The following sections only apply when there is a change in the product impacting this requirement or when this requirement is a change in the product. If there is no product change, erase this section (Design change management) when creating a new requirement record from this template.

Impact analysis​

  • Regulatory impact: Is the change classified as significant according to article 120 of MDR 2017/745?
    • Yes (it requires notification to Regulatory Authorities). If Yes, explain why and which Regulatory Authorities will be notified
    • No (it does not require notification to Regulatory Authorities). If No, add an explanation
  • Risk analysys impact: evaluate whether the change introduce new risks, modify exisiting risks
  • Process impact: evaluate whether the product change has an impact on any processes established in the QMS. If there is an impact, list the QMS processes.

Change description​

  • Source of change: Insert the source for this change (e.g. nonconformity ID, CAPA ID, customer complaint ID, etc.)
  • Description of change: Insert the proposed change(s) to be implemented in the product

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Tester: JD-017, JD-009, JD-005, JD-004
  • Approver: JD-003

Template signature meaning​

Instructions

Delete this section when you create a new record from this template.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Tester: JD-017, JD-009, JD-005, JD-004
  • Approver: JD-003
Previous
Templates
Next
T-012-003 Test run
  • Category
  • Source
  • Requirement type
  • Activities generated
  • Risks controlled by the requirement
  • Risks caused by the requirement
  • User Requirement, Software Requirement Specification, Design Requirement and Regulatory Requirements
  • Description
  • References
  • Design change management
    • Impact analysis
    • Change description
  • Template signature meaning
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.)