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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
      • 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 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-005 Human Resources and Training
  • Templates
  • T-005-008 PRRC designation

T-005-008 PRRC designation

Person Responsible for Regulatory Compliance (PPRC)​

Mr./Mrs. xxxxxxxxxxxxx, with ID xxxxxxxx, and nationality xxxxxxxxx.

On behalf of the company (Name of the company) with the identification number xxxxxxx and with address or registered address: xxxxxx, telephone xxxxxx, email xxxxxxxx, and as job position, I appoint xxxx, with ID number xxxxx and with title xxxxxx and professional experience in the regulatory field of medical devices according to the Regulation (EU) 2017/745, as PRRC.

That he/she will provide his/her services exclusively in this company, dedicating xx% of his/her time to his/her responsibilies as PRRC.

On xxxx the xx day of xxxx YYYY.

  • PRRC signature:
  • CEO signature:

Template signature meaning​

info

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

  • Author: JD-004 Giulia Foglia
  • Approval: JD-001 Andy Aguilar
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T-005-007 Technical Responsible designation
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T-005-009 QMS procedures training
  • Person Responsible for Regulatory Compliance (PPRC)
  • 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.)