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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
  • 15. Vendor services annex (non-normative)

15. Vendor services annex (non-normative)

Source: CER Template.pdf page 26 (document: Mantra Systems Free CER Template, Edition 2)

Note: this section is non-normative marketing material from the template vendor (Mantra Systems Ltd) and is NOT part of the MDR-required CER structure. Preserved here for faithful provenance only.

100% Guaranteed Clinical Evaluation Service​

Mantra Systems eliminates all Clinical Evaluation concerns through our market-leading Clinical Evaluation service.

  • CERs written for EU & UK MDR compliance
  • All classes of medical device in any clinical field
  • Fully insured ISO & TOPRA-registered consultants
  • Complete MDR, Meddev & MDCG compliant CER writing service
  • Appropriately qualified CER signatories

Uniquely, we offer a 100% money-back guarantee that any Clinical Evaluation prepared by us will receive full Notified Body acceptance following final review.

Contact our team to guarantee a fully compliant MDR Clinical Evaluation.

CER Review Service​

Mantra Systems offers a review service for CERs produced using this free template. Our professional CER writers will conduct a thorough review of your CER against comprehensive marking criteria, providing you with detailed feedback and closing gaps and omissions against requirements.

Deliverables include:

  • Completed checklist against line-by-line criteria
  • CER review report
  • Live one-to-one feedback call with a CER professional

Eliminate concerns over conformity and gain confidence and clarity in your CER submissions. Please contact our team to arrange your CER review.

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10. Clinical evidence analysis — Benefit-risk profile
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11–14. Conclusions, Author CVs, References, Excluded sources
  • 100% Guaranteed Clinical Evaluation Service
  • CER Review Service
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.)