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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 version 2.1 (Legacy MDD)
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 0: Background & Action Plan
        • 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
        • Item 7: Risk
        • MDCG 2020-13 & CER Template (reference)
          • MDCG 2020-13 (CEAR) sections
          • CER Template sections
            • 00 Front matter, introduction, writing tips
            • 1. Administrative particulars
            • 2. Executive summary
            • 3. Scope of the clinical evaluation
            • 4. Clinical evaluation plan — Summary
            • 5. Common specifications and harmonised standards
            • 6. Clinical background, current knowledge, state of the art
            • 7. Equivalence
            • 8. Clinical evidence review
            • 9. Clinical evidence analysis — GSPRs
            • 10. Clinical evidence analysis — Benefit-risk profile
            • 15. Vendor services annex (non-normative)
            • 11–14. Conclusions, Author CVs, References, Excluded sources
        • Adequacy review
        • Coverage matrix
        • task-3b2-3b3-legacy-rwe-study
        • task-3b4-mrmc-dark-phototypes
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • MDCG 2020-13 & CER Template (reference)
  • CER Template sections
  • 2. Executive summary

2. Executive summary

Source: CER Template.pdf page 8 (document: Mantra Systems Free CER Template, Edition 2)

Write this section last!

Although the Executive Summary will be one of the first parts of the final CER, do not try to populate the Executive Summary until the main body of the CER has been completed.

The Executive Summary should be a summary (2-3 pages) of the detail of the CER that follows. The Executive Summary should enable the reader to get a quick feel for the "story" told by the main body of the CER.

Structure the Executive Summary in a way that mirrors the structure of the main body of the CER, including a short summary of the "highlights" and main findings of each section.

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1. Administrative particulars
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3. Scope of the clinical evaluation
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.)