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      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-001 Quality objectives list_2026
      • 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-002-002 Quality objectives_2026_001
      • R-002-002 Quality objectives_2026_002
      • R-002-002 Quality objectives_2026_003
      • R-002-002 Quality objectives_2026_004
      • R-002-002 Quality objectives_2026_005
      • R-002-003 Quality indicators
      • R-002-004 Annual management review report 2025
      • R-002-004 Annual management review report 2026
      • R-002-005 Quality Calendar_2025
      • R-002-005 Quality Calendar_2026
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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 202520%Brazil: Awaiting ANVISA feedback on submitted technical dossier. USA: Continued preparation of FDA submission documentation. Japan/Saudi Arabia/Switzerland: Initial market assessment ongoing.Address any ANVISA feedback. Continue FDA documentation preparation.
Q2 202535%Brazil: Received ANVISA approval. Updated label and IFU with registration number. USA: Continued cybersecurity and usability documentation preparation. Other markets: On hold due to resource prioritization for MDR and FDA.Complete Brazil post-market setup. Continue FDA preparation.
Q3 202550%Brazil: Post-market surveillance system established. USA: Cybersecurity project completed with Dmed. Usability study preparation ongoing. Japan/Saudi Arabia/Switzerland: Remained on hold.Finalize FDA pre-submission package.
Q4 202560%Brazil: Fully operational in market. USA: Pre-submission meeting preparation ongoing, scheduled for Q2 2026. Japan/Saudi Arabia/Switzerland: On hold pending FDA and MDR completion.Execute FDA pre-submission meeting in Q2 2026.

Final status​

Status: Extended to 2026

  • Brazil: Completed ✅ - ANVISA approval obtained and device registered in market.
  • USA: Ongoing - FDA pre-submission meeting planned for Q2 2026, 510(k) submission to follow.
  • Japan, Saudi Arabia, Switzerland: On hold - Postponed to prioritize MDR certification and FDA clearance.

Related indicators​

The following quality indicators from R-002-003 are linked to this objective:

IDIndicatorTargetResult 2025Achieved
#22Number of communicated incidents to NCA00✅
#23Number of non-conformities related to vigilance/PMS≤30✅
#24Number of recalls00✅
#34Regulatory submissions completed≥51❌

Analysis of non-achievement​

Impact assessment​

AreaImpactJustification
QMS effectivenessNo impactThe QMS successfully supported the Brazil regulatory approval process, demonstrating its capability to manage international regulatory submissions. The FDA preparation is progressing according to plan with comprehensive documentation being developed.
Product quality and safetyNo impactThe product maintains its quality and safety profile across all markets. The Brazil approval confirms that the device meets international regulatory standards. No changes to product design or safety were required for market access.
Regulatory complianceNo impactBrazil approval (100%) demonstrates regulatory compliance capability. The FDA path is clearly defined with pre-submission meeting scheduled. Markets on hold are a strategic decision, not a compliance gap.
Customer satisfactionPositive impactBrazil market entry provides access to new customers. Existing markets continue to be served without interruption. The prioritization ensures resources focus on the most impactful regulatory pathways.

Root cause analysis​

The objective achieved 60% completion due to the following factors:

  1. Strategic prioritization: Resources were deliberately allocated to prioritize MDR certification (Quality Objective #1) and FDA preparation, as these represent the largest market opportunities and most critical regulatory pathways.
  2. Resource optimization: The organization made a conscious decision to focus on fewer markets with excellence rather than spreading resources thin across multiple simultaneous submissions.
  3. External dependencies: FDA timeline depends on pre-submission meeting outcomes and agency feedback, which are outside the organization's control.
  4. Market assessment: Japan, Saudi Arabia, and Switzerland were deprioritized after evaluation showed that MDR and FDA should be completed first to maximize regulatory efficiency (many technical requirements overlap).

Classification: Strategic decision. The 60% completion rate reflects deliberate business prioritization, not a failure of the quality system.

Corrective actions​

No corrective actions required.

The partial achievement is the result of strategic resource allocation, not process deficiencies:

  1. Brazil (100% achieved): Demonstrates the organization's capability to successfully complete international regulatory submissions.
  2. USA (ongoing): Pre-submission meeting scheduled for Q2 2026 shows clear progress and defined pathway.
  3. Other markets (on hold): Strategic decision documented and justified based on regulatory synergies and resource optimization.

Actions for 2026:

  • Execute FDA pre-submission meeting (Q2 2026)
  • Submit 510(k) following FDA feedback
  • Reassess Japan, Saudi Arabia, and Switzerland timelines after MDR/FDA completion
  • Update R-002-008 Quality and regulatory roadmap based on 2025 outcomes

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: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & Person Responsible for Regulatory Compliance (PRRC)
  • Approver: JD-001 General Manager

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: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & Person Responsible for Regulatory Compliance (PRRC)
  • Approver: JD-001 General Manager
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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
    • Final status
  • Related indicators
  • Analysis of non-achievement
    • Impact assessment
    • Root cause analysis
    • Corrective actions
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