Clinical evaluation

Spend more time evaluating evidence. Less time assembling the report.

Bevrik’s approach connects the search strategy, study findings and working clinical documents. Your team can follow each conclusion back to its source and focus on the evidence gaps, safety and performance questions that need expert judgment.

Less paperwork. More confidence.

Clinical evaluation screening workspace with four fictional sample articles, candidate IDs, years and review statuses.
Illustrative workspace with fictional sample articles.
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Where the hours go

The search ends. The preparation keeps going.

Screening papers is only part of the work. Your team still has to appraise the full texts, extract results, check citations and carry the findings into the CEP and CER.

When the sources, notes and report drafts are separate, every update brings another round of copying and checking. Keep the findings and review context connected so your specialists can spend more time weighing the evidence.

The workflow

A clear path from your device to your documents.

  1. 1

    Describe your device

    Provide your device description, intended purpose, patient population, variants and manufacturer-controlled claims. These inputs define the questions the literature needs to answer.

  2. 2

    Search and evaluate evidence

    Review the proposed search strategy, then search and screen publications. Retrieve or upload full texts for appraisal, recording inclusion and exclusion decisions before finalizing the Literature Search Report.

  3. 3

    Review the findings

    Review the full texts in detail and extract study characteristics, safety and performance results with supporting source passages. Compare subject-device evidence with the state of the art, keeping limitations and evidence gaps visible.

  4. 4

    Prepare working documents

    Use reviewed evidence and manufacturer inputs to prepare the clinical evaluation plan and section-by-section report. Your team checks the content before export and completes formal approval through its own document-control process.

Clinical evaluation documents

Three documents. Clear links to the evidence.

These documents bring together your device information, search methods and reviewed evidence.

Clinical Literature Search Report

A record of the search questions, terms, databases, dates and criteria, with selected publications, objective summaries, appraisal decisions, exclusions and reasons, search-flow counts and limitations.

Clinical Evaluation Plan (CEP)

A working plan defining the clinical questions, methods, objectives and acceptance criteria, state-of-the-art approach, evidence needs and links to planned follow-up where applicable.

Clinical Evaluation Report (CER)

A reviewable report draft bringing together device information, clinical evidence, state-of-the-art comparisons, safety and performance results, benefit-risk discussion, references and disclosed evidence gaps.

Review the study results, source passages and decisions behind each document. Missing or conflicting evidence needs attention, not an invented answer.

Working documents need qualified review. Your team handles formal approval and signatures through its own document-control process. Ask us about the document formats and export options that fit your workflow.

Reviewable evidence

Keep the source, the finding and the decision together.

Check the source

Retain publication references and supporting passages with study findings. Reviewers can inspect what was reported rather than rely on a summary alone.

Keep clinical context clear

Separate subject-device evidence from state-of-the-art evidence. Keep study limitations and missing or conflicting results visible during the clinical analysis.

Carry the review forward

Use reviewed findings in working document sections, with their source context available for checking. AI interpretations remain proposals, not final clinical judgments.

Your qualified team checks the evidence and conclusions. Formal approval and signatures stay in your own document-control process.

The work that needs your expertise

Put more attention on the clinical questions.

Safety and performance

Assess whether the evidence supports your device, intended purpose and manufacturer-controlled claims.

Evidence gaps

Decide what incomplete or conflicting findings mean and what additional evidence or follow-up your device needs.

A reviewable conclusion

Explain the clinical reasoning, benefit-risk discussion and limitations in a working report that your reviewers can assess.

From research to your next step

Continue with your task.

Read a practical guide, find a starting document and explore how Bevrik supports the work.

Start with one recurring task

Which part of your next clinical evaluation takes the most preparation?

Pick the task that takes too much preparation. Walk through the Bevrik approach, confirm the available workflow and identify the review your team would still need to do.