Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
          • Request A: PMCF Activity Descriptions
            • Question
            • Research and planning
          • Request B: PMCF Data Sufficiency Justification
        • Item 7: Risk
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 6: PMCF Plan
  • Request A: PMCF Activity Descriptions
  • Question

Question

Please address all points above.

Please provide a full and comprehensive description of each activity (including any supporting documents such as plans and protocols), including (but not limited to) the points discussed above, or direct reviewer to where this is included in the PMCF plan.

Previous
Item 6: PMCF Plan
Next
Research and planning
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.)