Description

CER Literature Tools: Transform Your Clinical Evaluation Report Process

Are you struggling with the time-consuming literature search requirements for EU MDR 2017/745 compliance?

Our CER Literature Tools Excel add-in and template revolutionizes how medical device professionals manage literature searches for Clinical Evaluation Reports. Designed specifically to address the rigorous documentation requirements of MDR 2017/745, this powerful tool helps you create comprehensive, compliant CERs in significantly less time. This tool was created in compliance with not only the EU MDR 2017/745, but relevant MDCG Guidance documents and feedback and input from experienced Notified Body reviewers.

Comprehensive Literature Management System

The foundation of any good Clinical Evaluation Report is a thorough literature review. Our add-in and template transforms Excel into a specialized literature management system:

• Seamless Data Import: Import citations directly from RIS files exported from all major medical databases including PubMed, Embase, Scopus, and Cochrane Library. No more copy-pasting or manual data entry.
• Structured Database Creation: Automatically organize imported references with all critical fields maintained including authors, title, journal, publication date, abstract, and DOI links.
• Transparent inclusion and exclusion reasoning: Logical and intuative workflow for evaluating citations and recording rationales for inclusion or exclsuion, as demanded by Notified Body reviewers.
• Intelligent Duplicate Detection: Our sophisticated algorithm identifies duplicate studies across multiple database searches, even when citation formats differ. This ensures your PRISMA flow diagram accurately reflects unique studies.
• Visual Duplicate Highlighting: Easily spot and manage duplicates with visual indicators, helping you maintain clarity throughout your review process.

RIS Import Example:

 

Duplicate detection Example:

Professional Output Generation

Presentation matters when submitting your CER for review. Our tools help you create professional documentation:

• Automated PRISMA Diagrams: Generate publication-quality PRISMA flow diagrams with a single click. The system automatically calculates all the numbers based on your screening decisions.
• Word Export Functionality: Export your entire literature review, including search strategies, inclusion/exclusion criteria, and study summaries directly to Word format ready for inclusion in your CER.
• Customizable Reporting: Tailor your exports to match your specific CER template requirements, making integration seamless.

PRISMA Diagram creation Example:

Why Choose CER Literature Tools?

• Lightweight and local: Runs directly on your local machine. No accounts, subscriptions or logins required.
• Significant Time Savings: Users report 50-70% reduction in time spent on literature search documentation.
• Regulatory Compliance Confidence: Designed specifically to meet EU MDR 2017/745 requirements for literature evaluation.
• Error Reduction: Structured approach prevents common mistakes in reference management and documentation.
• Team Collaboration Enhancement: Standardize how your entire regulatory team handles literature reviews across all your device portfolios.
• Learning Curve Elimination: Intuitive Excel-based interface means no complex new systems to learn.

Who Needs This Tool?

• Medical Device Manufacturers facing MDR transition deadlines
• Regulatory Affairs Specialists managing CER updates
• Clinical Evaluation Report Writers seeking efficiency
• CER Consultants handling multiple client projects
• Quality Assurance Professionals ensuring documentation compliance
• Medical Writers specializing in regulatory documentation

Stop struggling with makeshift spreadsheets and manual processes for your clinical evaluation report literature searches. Let CER Literature Tools transform your approach to literature management, helping you create thorough, compliant clinical evaluation reports with confidence and efficiency.

“How to write a clinical evaluation report becomes significantly easier when your literature search process is optimized. Our tool was created by CER writing professionals who understand the challenges you face under EU MDR 2017/745.”

Compatible with Excel 2010 or newer on Windows. Includes perpetual license for up to 3 installations.

Ongoing Support, Development and Refunds

This tool was created in-house by Practical RA. We are continually adding new features and capabilities to the tool to continually improve its functionality and expand capabilities. Your perpetual license grants you access to all improved and advanced future versions of this Excel add-in.

We are confident you will be satisfied with this tool but if not, we have a 48-hour full refund policy on this product. Please email support@practicalra.com with your Order Number and email, and we can process the refund for you.