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      • 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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  • R-002-002 Quality objectives_2024_001

R-002-002 Quality objectives_2024_001

Objective details​

Objective number​

1

Description​

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

Establishment date​

February 2024

The objective was established 2 years ago and it has been extended during the annual management review on February 13, 2024 because it is not fully achieved: we are waiting for further feedback on the technical documentation submitted to BSI.

Planning​

Responsible​

JD-005 and JD-004.

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 2024 period​

  1. Address any further BSI questions coming from the technical documentation review.
  2. Improve the current technical documentation when required.

Resources needed​

  • Personnel for product development and quality and regulatory activities to follow up with any further questions on the technical documentation.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202460%We submitted the second round of answers related to the technical documentation on March 27, 2024Since we didn't answer all the questions of the reviewers of the technical documentation, we will adress the unanswered questions before the third round of questions. Main topic unanswered: usability testing
Q2 202490%We submitted the third (and last) round of answers related to the technical documentation on July 8, 2024 (including updated technical documentation). The main changes implemented to answer some of the BSI questions are: - planning and execution of a new summative evaluation test to gather new evidence - restructuring of the DHF to differentiate between test plan and test report and migration of the DHF in the QMSThis was the last round of questions, therefore we will wait for the final decision of the BSI. In the meantime, we will continue improve the technical documentation as needed.
Q3 202492%On August 15, 2024, we received the first round of question of the clinical review and we agreed with BSI on submitted our responses together with updated documentation by November 15, 2024. On September 18, 2024, we received the final outcome of the thirst round of questions of the technical review: BSI notified us that, despite the progress done during the review, there are still some significant gaps in the technical documentation that have led to the recommendation for refusal (of the CE certificate under MDR). BSI let us decide whether to continue with the clinical review, although a positive outcome of the clinical review will not change the decision on the recommendation for refusal. After this feedback, we put our effort on ensuring that we had a signed agreement with BSI in place before September 26, 2024 (deadline established by European Commission to be able to continue placing in the market legacy device). We fulfilled the objective of having a new contract with BSI and the last information from BSI is that we will be notified about the decision on how to proceed with the MDR certification. The options are the following: - Re-start the certification process: we re-start the certification from the beginning (submission of technical documentation, technical and clinical review, up to 3 rounds of questions) - Nonconformity pilot trial: we fix the gaps in the technical documentation and we finish the rounds of question of the clinical review. In the meantime, we are working on the first round of questions of the clinical review and on the gaps identified in the technical review.- Follow up with BSI to have a final decision on the path for the MDR certification - Finalise the clinical review questions and update the required clinical documentation - Fix the gaps identified in the technical documentation (main comments are related to the usability test, software requirements and testing, risk management)
Q4 202492%During the last quarter of 2024, we received additional details of the available paths to finalise the MDR transition and we decided to go for the nonconformity pilot trial. This path consists on receiving minor/major nonconformities related to our technical documentation that we will need to address during an established period of time based on the criticality of the nonconformity. Usually the period given to solve minor nonconformities is of 6 months, while for major nonconformities is 3 months. BSI notified us that we will receive the nonconformities at the beginning of 2025. Meanwhile, we are working on filling in the gaps already identified in our technical and clinical documentation to be ready to address the nonconformities on time.- Address the pending gaps in the technical and clinical documentation

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: JD-004
  • Reviewer: JD-001
  • Approver: JD-001
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  • Objective details
    • Objective number
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2024 period
    • Resources needed
  • Monitoring and follow up
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.)