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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
      • Templates
        • T-005-001 Job Description
        • T-005-003 Training plan YYYY_nnn
        • T-005-004 Training evaluation and record
        • T-005-006 GDPR training
        • T-005-007 Technical Responsible designation
        • T-005-008 PRRC designation
        • T-005-009 QMS procedures training
        • T-005-010 Email footer generator
        • T-005-011 Assignment of Image Rights
      • Specific procedures
    • 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
    • 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 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery And Comissioning
    • 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
  • Applicable Standards and Regulations
  • Grants
  • Public tenders
  • Procedures
  • GP-005 Human Resources and Training
  • Templates
  • T-005-008 PRRC designation

T-005-008 PRRC designation

Designation​

Configuration

The purpose of this document is to formally appoint a Person Responsible for Regulatory Compliance (PRRC) in accordance with the requirements set forth in the Medical Device Regulation (EU) 2017/745.

To that end, we hereby appoint Full name of designee, with national identification number ID number, holding a degree in Degree and professional experience in the field, to said position. They will provide services exclusively to our company, allocating 100% of their time to this role.

Full name of designee
Ms. Aguilar Robles
Received and acknowledgedCertifies that the knowledge has been acquired

Company Identifying Information​

PropertyValue
Company nameAI Labs Group, S.L.
TrademarkLegit.Health ®
ID Number(ES)B95988127
ActivityProvision of clinical intelligence and communication software for HCP.
AddressGran Via, BAT Tower, 48001, Bilbao, Spain
Telephone+34 653 08 83 37
Emailhello@legit.health
Websitehttps://legit.health
Legal representativeMs. Aguilar Robles

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:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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T-005-007 Technical Responsible designation
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T-005-009 QMS procedures training
  • Designation
  • Company Identifying Information
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.)