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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • CAPA Plan - BSI CE Mark Closeout
    • Index
    • Overview and Device Description
      • R-TF Summary of Technical Documentation (STED)
      • R-TF Device Description and Specification
      • R-TF-001-007 EU Declaration of Conformity
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Overview and Device Description

Overview and Device Description

📄️ R-TF Summary of Technical Documentation (STED)

This Summary of Technical Documentation (STED) provides a concise overview of the complete technical documentation for Legit.Health Plus as required for BSI (Notified Body) review under MDR 2017/745. This document follows the structure recommended by GHTF/IMDRF and facilitates the understanding of the device's safety, performance, and regulatory compliance without requiring immediate review of every detailed report.

📄️ R-TF Device Description and Specification

This section complies with MDR 2017/745 Annex II, Part 1, Section 1.

📄️ R-TF-001-007 EU Declaration of Conformity

This document is a draft version pending final certification by BSI.

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R-TF Summary of Technical Documentation (STED)
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.)