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      • Deprecated
        • R-002-001 Quality objectives list_2023_001
        • R-002-002 Quality objectives_2023_001
        • R-002-002 Quality objectives_2023_002
        • R-002-002 Quality objectives_2023_003
        • R-002-002 Quality objectives_2023_004
        • R-002-002 Quality objectives_2023_005
        • R-002-002 Quality objectives_2023_006
        • R-002-003 Quality indicators_2022_001
        • R-002-003 Quality indicators_2023_001
        • R-002-004 Annual management review report_2023_001
        • R-002-005 Quality Calendar_2023_001
        • R-002-005 Quality Calendar_22_001
        • R-002-006 SWOT and CAME analysis_2023_001
        • R-002-007 Process validation card 2023_013
        • R-002-008 Quality and regulatory roadmap_2023_001
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-003 Quality indicators_2024
      • R-002-004 Annual management review report
      • R-002-005 Quality Calendar_2025
      • R-002-006 SWOT and CAME analysis
      • R-002-007
      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
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    • GP-200 Remote Data Acquisition in Clinical Investigations
  • TF_Legit.Health_Plus
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  • GP-002 Quality planning
  • Deprecated
  • R-002-002 Quality objectives_2023_001

R-002-002 Quality objectives_2023_001

Objective details​

Objective number: 1​

Description​

Certify with a notified body the new Class IIa medical device Legit.Health Plus.

Establishment date​

January 2022

The objective was established last year as it is a long term objective. Notified bodies have a high waiting list due to the new European regulations for the MD and IVD. We are taking advantage of this to improve the QMS in place and all the documentation required.

Planning​

Responsible​

JD-005

Departments involved​

As it is a huge objective, all the departments are involved, but the main departments developing the objective are Design & Development and Quality & Regulatory ones.

Planned actions for 2023 period​

  1. To sign a contract with a Notified Body
  2. Gather data from the use of the current medical device
  3. Complete the documentation required for the Technical File:
    3.1. Complete the clinical trials by 3Q 2023
    3.2. Complete the papers publication that are ongoing (ALADIN, AIHS4, UAS and melanome) before end of 3Q 2023
    3.3. Complete the TF with the results of the clinical trials and other updates

Resources needed​

  • Financial resources for the Notified Body payment (aproximately 85k €): the Notified Body selected is BSI.
  • Personnel for product development and quality and regulatory activities.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202350%TF being prepared. We are performing the planned actions to achieve the objective on timePapers being finished to send to the journals
Q2 202360%We signed a contract with BSI as our Notified Body. We continue with the TF completion. AIHS4 paper was finally published.Minor review on ALADIN paper being performed to be published. To confirm the dates of the first audits with BSI.
Q3 202375%We have almost completed the TF of the device. We have fixed with BSI the dates for the different audits for the QMS and TF.Complete the TF and upload all the documents required by BSI by 30th October.
Q4 202395%We completed the TF and submitted it to the Notified Body. During last December they performed the first review of the technical documentation and sent us the first round of questions. We completed the documentation following their recommendations and submitted back our responses and updated documentation by the end of January.Wait for the second round of questions while improving the TF when required

Status​

  • [] In progress
  • [] Completed
  • Extended
  • [] Discarded

Record signature meaning

  • Author: JD-004 María Diez
  • Review and approval: JD-001 Andy Aguilar
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  • Objective details
    • Objective number: 1
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2023 period
    • Resources needed
  • Monitoring and follow up
  • Status
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.)