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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
    • GP-003 Audits
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    • GP-007 Post-market surveillance
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    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-002 Quality planning
  • R-002-002 Quality objectives_2025_002

R-002-002 Quality objectives_2025_002

Objective details​

Objective number​

2

Description​

Obtain regulatory clearance in new markets

Establishment date​

January 2025

This objective is an extension of the objective 3 established last year and documented in the record R-002-002_2024_003. We decided to extend it to 2025 because during 2024 we reviewed and changed the regulatory roadmap and we didn't complete the quality objective of obtaining regulatory approval in the established countries. This objective includes the markets that have been agreed upon and documented in the R-002-008 Quality and regulatory roadmap for 2025.

Planning​

Responsible​

JD-005, 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 2025 period​

The selected markets (except for Europe that is already covered by the quality objective 1) are:

  • Brazil
  • USA
  • Japan
  • Saudi Arabia
  • Switzerland

Brazil​

We started the registration process in 2024, as detailed in the record R-002-002_2024_003.

The planned actions for 2025 are:

  1. Address any feedback coming from ANVISA on the technical dossier
  2. Update the label and IFU of the device with the ANVISA registration number, upon approval.

USA​

We started working on the FDA approval project in 2024, as better detailed in the record R-002-002_2024_003.

The planned actions for 2025 are:

  1. Finalise the IFU for the US market
  2. Perform and document a usability study in USA
  3. Review and create, when needed, the required cybersecurity records
  4. Review the DHF software requirements structure and documentation to comply with FDA requirements
  5. Review the DHF software test documentation to comply with FDA requirements
  6. Prepare the pre-submission meeting package based on the FDA template
  7. Execute the pre-submission meeting with FDA
  8. Implement any FDA feedback on the technical documentation
  9. Submit 510(k) to FDA

Once we receive feedback from FDA during the pre-submission meeting, we will provide more details on specific actions.

Japan​

This is a new market identified for 2025 and the foreseen actions are:

  1. Have a first meeting with a regulatory consultancy company in Japan to understand the possible regulatory paths for our device
  2. Define the regulatory path based on the risk classification of our device and other factors (such as availability of predicate devices in the japanese markets)
  3. Search and appoint an authorised representative based in Japan
  4. Review the applicable regulatory requirements
  5. Implement necessary changes in the technical documentation
  6. Submission of technical documentation
  7. Creation of a procedure in the QMS to document the process to register our medical device in Japan and to document the post-market requirements.

Once the regulatory path is clarified, more details actions will be added to this section.

Saudi Arabia​

In 2024 we started reviewing applicable regulatory requirements and we contacted potential authorised representatives.

The planned actions for 2025 are:

  1. Select an authorised representative based in Saudi Arabia
  2. Review the applicable regulatory requirements
  3. Implement necessary changes in the technical documentation
  4. Submission of technical documentation
  5. Creation of a procedure in the QMS to document the process to register our medical device in Saudi Arabia and to document the post-market requirements.

Switzerland​

This is a new market identified for 2025. The planned actions are:

  1. Search and appoint an authorised representative based in Switzerland
  2. Creation of a procedure in the QMS to document the process to register our medical device in Switzerland and to document the post-market requirements.

Resources needed​

  • Personnel from product development and quality and regulatory teams to implement the applicable regulatory requirements in the technical documentation.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 2025
Q2 2025
Q3 2025
Q4 2025

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 2025 period
      • Brazil
      • USA
      • Japan
      • Saudi Arabia
      • Switzerland
    • 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.)