Systematic Literature Review
Transforming Complex Literature Into Clear Regulatory Insights
Systematic Literature Review Services Overview
Our PRISMA- and MEDDEV-aligned methodology delivers high-quality evidence compliant with EU MDR.
Clinical Literature Review (CLR)
- Identifying, screening, and synthesizing published clinical evidence
- Supporting CER, CEP, PMS, PMCF, and Risk Management
- Transparent, reproducible documentation per MEDDEV & PRISMA
SOTA / Benchmark Literature Review
- Reviewing standard of care, alternative therapies, and clinical benchmarks
- Establishing minimum safety & performance expectations
Risk & Safety Literature Review
- Adverse events, complications, and long-term safety signals
- Inputs for risk management and benefit–risk justification
Systematic Literature Review (SLR) Offerings
We execute end-to-end SLRs aligned with PRISMA, MEDDEV 2.7/1 Rev.4, and MDR expectations.
Search Strategy Development
Defining keywords using the PICO method and creating search strings using Boolean logic.
Database Searches
Structured searches across PubMed, Embase, Cochrane, Google Scholar, and device-specific scientific sources.
Screening & Classification
Includes defining clear inclusion and exclusion criteria and performing two-step screening from title/abstract to full text, followed by classification based on clinical relevance.
Critical Appraisal of Literature
Evaluating study quality, bias, applicability, and statistical robustness.
Evidence Synthesis & Reporting Offerings
Evidence Summaries for CER / PMS / PMCF
Consolidated tables capturing clinical outcomes, safety trends, and device performance.
SOTA Literature Synthesis
Comparing device safety and performance against current clinical practice and available alternatives.
Safety & Risk Literature Mapping
Extracting adverse events, complications, and safety warnings to support ISO 14971 compliance.
Transparent PRISMA Documentation
Includes PRISMA flow diagrams, screening logs, classification matrices, and reviewer comments.
Our SLR Deliverables
PRISMA Flow Diagram
Search Strategy Documentation
Screening Logs & Classification Sheets
Critical Appraisal Tables
Evidence Summary Tables
SOTA Literature Summary
EndNote Reference Library
Full SLR Report for CER / PMS / PMCF
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Contact Our MedTech Experts
Cetas Healthcare is the world’s leading boutique MedTech market research firm. We blend agency-grade research with strategic intelligence frameworks to track pipelines, regulatory shifts, clinical trials, and GTM strategies. As pioneers of ISO 14155-compliant PMCF surveys, we’ve managed 25,000+ patient case forms for Class II & III devices, helping clients secure CE certifications and stay ahead of EU MDR requirements.
Contact Us: communication@cetas-healthcare.com
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