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      • Deprecated
      • R-002-001 Quality objectives list_2024_001
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      • R-002-002 Quality objectives_2024_003
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      • R-002-002 Quality objectives_2025_001
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      • R-002-002 Quality objectives_2025_005
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      • R-002-007
      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
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  • GP-002 Quality planning
  • R-002-008 Quality and regulatory roadmap

R-002-008 Quality and regulatory roadmap

Roadmap​

info
  • Europe (MDR certification): we have been enrolled in the so called nonconformity pilot trial scheme; we are going to receive nonconformities on our technical and clinical documentation and we will have to address them between 3 and 6 months, depending on the type of nonconformity (minor or major).
  • USA (FDA): we are going to pursue the 510(k) submission by using the DermaSensor device as predicate device to claim equilavence with.
  • Brazil: we submitted the technical dossier to ANVISA in December 2024, we are waiting for ANVISA feedback.
  • Japan: we will have a first meeting with a regulatory consultant company in Japan in the second week of January 2025 to start understanding the possible regulatory pathways based on the risk classification of our device. Once we have more clarity on the regulatory path, we will update the roadmap with more precise activities.
  • Saudi Arabia: at the end of 2024 we contacted three possible authorised representatives; in 2025 we will select one of them and we will start the regulatory process for submission of the technical documentation to Saudi FDA (SFDA).
  • Switzerland: in 2025 we will search for an authorised representative and have in place a signed contract.

Record signature meaning

  • Author: JD-004
  • Review and approval: JD-001
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R-002-007 Process validation card 2024_002
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