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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

CER Template sections

Section-by-section markdown transcription of the Mantra Systems Free CER Template (Edition 2). 14 numbered sections covering an MDR-compliant CER.

📄️ 00 Front matter, introduction, writing tips

Source Mantra Systems Free CER Template, Edition 2)

📄️ 1. Administrative particulars

Source Mantra Systems Free CER Template, Edition 2)

📄️ 2. Executive summary

Source Mantra Systems Free CER Template, Edition 2)

📄️ 3. Scope of the clinical evaluation

Source Mantra Systems Free CER Template, Edition 2)

📄️ 4. Clinical evaluation plan — Summary

Source Mantra Systems Free CER Template, Edition 2)

📄️ 5. Common specifications and harmonised standards

Source Mantra Systems Free CER Template, Edition 2)

📄️ 6. Clinical background, current knowledge, state of the art

Source Mantra Systems Free CER Template, Edition 2)

📄️ 7. Equivalence

Source Mantra Systems Free CER Template, Edition 2)

📄️ 8. Clinical evidence review

Source Mantra Systems Free CER Template, Edition 2)

📄️ 9. Clinical evidence analysis — GSPRs

Source Mantra Systems Free CER Template, Edition 2)

📄️ 10. Clinical evidence analysis — Benefit-risk profile

Source Mantra Systems Free CER Template, Edition 2)

📄️ 15. Vendor services annex (non-normative)

Source Mantra Systems Free CER Template, Edition 2)

📄️ 11–14. Conclusions, Author CVs, References, Excluded sources

Source Mantra Systems Free CER Template, Edition 2)

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00 Front matter, introduction, writing tips
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