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  • R-002-002 Quality objectives_2024_003

R-002-002 Quality objectives_2024_003

Objective details​

Objective number​

3

Description​

Register medical device in Mexico, Brazil and USA.

Establishment date​

February 2024.

During the annual management review on February 13, 2024, we established this new quality objective to address weaknesses coming from the SWOT & CAME analysis.

During the month of April 2024, we decided to include in this quality objective the registration of our medical device in USA because it is the main market where we aim to obtain approval, therefore resources will be placed in obtaining the FDA approval.

Planning​

Responsible​

JD-004

Departments involved​

As it is a huge objective, all the departments are involved, but the main department developing the objective is Quality & Regulatory. Sales team will be also involved, especially for the registration in Brazil, to better understand the market requirements.

Planned actions for 2024 period​

  1. Analyze regulatory requirements to place medical device in Mexico, Brazil and USA
  2. Appoint an authorize representative in Mexico and Brazil
  3. Gap analysis between our current documentation and specific in-country requirements
  4. Implementation of required changes in the documentation, execution of testing (when required)
  5. Provide the required documentation to the authorized represenattives in Mexico and Brazil to be used for the submission to Competent Authorities (COFREPIS, Anvisa)
  6. Submission of required documentation to FDA
  7. Follow up with potential clarifications requested by Competent Authorities (COFREPIS, ANVISA, FDA).

Resources needed​

  • Personnel for product development and quality & regulatory departments.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
Q1 202415%During the first quarter of 2024, we had a follow up with Apotech consulting (consulting company supporting us with the registration of our medical device in Mexico) to understand the next steps for the registartion process. We received from Apotech consulting an updated list of documentation we need to submit to the Competent Authority in Mexico (COFREPIS) and a name for a potential Authorised Representative in MexicoAnalyze the list of required documentation to understand whether we need to modify existing documentation and/or creating new documentation. Evaluate the potential Authorised Representative
Q2 202425%During the second quarter of 2024, we decided to include in this quality objective the FDA approval project because it is the top priority for this year. Therefore, the registration process in Mexico and Brazil is temporarly on hold to focus resources in the FDA approval project. With regards to the FDA approval project, during the second quarter the following activities have been done: - research and selection of a provider to support us on regulatory matters related to FDA requirements (approved provider: CMG MedDev) - research and selection of a provider to support us on cybersecurity topic according to FDA requirements (final decision to be made) - research and selection of a provider to support us on human factors according to FDA requirements (final decision to be made) - understanding of Pre-Submission meeting process - search of predicate devices - initial plan definition- Gap analysis between our current documentation and FDA requirements - Implementation of required changes in our current documentation according to the outputs of the gap analysis - Selection of provider for cybersecurity testing and documentation updates - Selection of provider for human factors testing and documentation updates - Start working together with the selected providers for cybersecurity and human factors testing and documentation updates
Q3 202430%During the third quarter we accomplished the following in relation to the FDA approval project:
- We defined the regulatory strategy: we decided to go for the 510(k) regulatory path because we identify DermaSensore device as predicate device to claim equivalence
- We selected and started working with the providers for cybersecurity testing (Dmed software) and for usability testing (Design Science)
- We defined the intended purpose of our device taking into consideration the predicate device's intended pupose and the applicable FDA guidances.
During the third quarter we accomplished the following in relation to the registration of our device in Brazil (ANVISA registration):
- We classified our device according to the risk class rules and we identified the applicable requirements
- We selected the registration holder in Brazil (Brisa) responsible for the interaction with ANVISA
- We identifed the required documents to be submitted to ANVISA for approval		Next steps for FDA approval project:
- work on the cybsercurity procedure and records (including penetration test reports)
- work on the usability testing protocol
- Fill in the 510(k) template with the information related to our device
- Prepare the comparison table between our device and the predicate device
- Prepare a table with the summary of pre-clinical tests
- Prepare a table with the summary of clinical studies
Next steps for ANVISA approval:
- review and sign agreement with the registration holder (Brisa)
- share required technical documentation with registration holder for submission to ANVISA
Q4 202440%During the last quarter of 2024, we achieved the following in relation to the FDA approval project:
- We worked on IFU and Use Related Risk Analysis (URRA) documents to enable the preparation of the usability study protocol by Design Science
- We scheduled the initiation date of the cybersecurity project with our selected and approved provider (Dmed software)
- We identified all the required documents to be submitted to FDA
- We analysed the FDA guidance on software documentation to identify potential gaps in the design documentation
- We established a new structure of the DHF software requirements to comply with the FDA guidance.
During the last quarter of 2024, we achieved the following in relation to the registration of our device in Brazil (ANVISA registration):
- We signed a written agreement with the selected authorised representative in Brazil
- We prepared the required documentation to be submitted to ANVISA
- Our authorised representative submitted the technical dossier to ANVISA
- We created a procedure to document the requirements to place our medical device in the Brazilian market and vigilance requirements		Next steps for FDA approval project:
- work on the cybsercurity records
- work on the usability test protocol
- Fill in the 510(k) template with the information related to our device
- Prepare the comparison table between our device and the predicate device
- Prepare the software documentation.
Next steps for ANVISA approval:
- Address nonconformities raised by ANVISA, if any.

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 & PRRC
  • Approver: JD-001 General Manager
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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
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