Clinical Evaluation of Medical Devices

Masuu Global Solutions is your trusted partner for conducting Clinical Evaluation across all classes of medical devices. We develop robust Clinical Evaluation Plans (CEP), execute reproducible Systematic Literature Reviews (SLRs), and author high quality Clinical Evaluation Reports (CERs) that clearly demonstrate safety, performance, and compliance with EU MDR 2017/745—fully prepared for Notified Body scrutiny.

Clinical Evaluation of Medical Devices – Overview

Masuu delivers end to end Clinical Evaluation services using rigorous methodologies, transparent State of the Art (SOTA) justification, and lifecycle based maintenance. From CEP development to CER writing, PMCF planning, and continuous updates, we align every element of your evidence package with General Safety & Performance Requirements (GSPRs) and MDR expectations. Our approach ensures your submissions are scientifically sound, fully traceable, and Notified Body–ready.

Masuu’s Tailored Clinical Evaluation Services

  1. Clinical Evaluation Gap Analysis
    2.
    We identify gaps in your existing CERs relative to MDR expectations and GSPRs.
    Our assessment includes:
    • Methodological alignment
    • Equivalence strategies
    • Benefit–risk justification
    • State of the art accuracy
    • Traceability and document consistency

    Masuu delivers a prioritized remediation roadmap with clear evidence recommendations and NB ready rationales to prevent non conformities and accelerate approvals.

  2. Tailored Literature Strategy & Systematic Literature Review (SLR)
    3.
    Masuu develops customized literature review strategies:
    • Multi database searches
    • Dual screening workflow
    • Critical appraisal using validated criteria
    • Structured evidence synthesis
    • PRISMA style documentation
    • Full traceability matrices

    Our SLR outputs establish a defensible State of the Art baseline and directly strengthen the CER.

  3. SME Support for Non Conformity (NC) Review
    4.
    If Notified Bodies raise NCs, Masuu mobilizes senior clinical writers and regulatory experts to:
    • Interpret NB findings
    • Refine equivalence arguments
    • Strengthen benefit–risk justifications
    • Improve appraisal and SLR methodology
    • Prepare persuasive, audit ready NB responses

    This reduces review cycles and speeds up CER approval.

  4. SOP Development for Clinical Evaluation
    5.
    Masuu designs MDR aligned SOPs covering:
    • CEP development
    • Literature search and appraisal
    • Equivalence assessment
    • Benefit–risk evaluation
    • Traceability requirements

    Our SOPs establish consistent, repeatable workflows that withstand audits and enable high quality CER output across teams.

  5. Annual CER Maintenance
    6.
    We manage periodic CER updates by integrating:
    • PMS trends
    • Vigilance and incident reports
    • PMCF findings
    • New clinical and scientific literature
    • Market and regulatory changes

    Your CER stays up to date, traceable, and audit ready across the EU MDR lifecycle.

  6. Full Time Employee (FTE) Support
    7.
    Masuu deploys dedicated FTE resources to strengthen your internal capabilities with:
    • CER writing specialists
    • Clinical evaluation SMEs
    • SLR experts
    • PMCF strategists

    Our specialists bring Notified Body–facing experience and ensure high quality submissions with scalable capacity.

  7. Procedural Training on Clinical Evaluation
    8.
    We offer hands on training tailored to your team’s needs:
    • MDR clinical evaluation fundamentals
    • Literature search methodology
    • Equivalence and benefit–risk justification
    • SSCP/PSUR integration
    • Best practices for CER writing

    Your teams gain the skills necessary to produce consistent, compliant, and audit ready evaluations.

    Masuu’s Clinical Evaluation Deliverables

    Clinical Evaluation Plan (CEP)

    We develop device specific CEPs defining:
    • Intended purpose & indications
    • Evaluation objectives & claims
    • Acceptance criteria
    • Equivalence strategy
    • SLR methodology
    • Traceability mapping

    Systematic Literature Review (SLR)

    Masuu conducts:
    • Multi database searches
    • Dual screening
    • Critical appraisal
    • Evidence grading
    • Structured synthesis

    All delivered with PRISMA documentation and traceability matrices.

    Clinical Evaluation Report (CER)

    Our CERs include:
    • Device description & clinical background
    • State of the Art
    • Appraisal & analysis of clinical data
    • Comprehensive benefit–risk evaluation
    • Residual risk justification
    • PMCF linkage
    • GSPR mapping

    We also manage ongoing CER updates aligned with PMS and PSUR cycles.

    Summary of Safety and Clinical Performance (SSCP)

    We prepare clear, compliant SSCPs with:
    • Device purpose & intended use
    • Clinical performance summary
    • Benefit–risk profile
    • Residual risks
    • Evidence traceability to CER/PMS/PMCF
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