Simplify the Complexities of Clinical Evaluations
CER Navigator: Making MDR and MDCG Compliant Clinical Evaluation Reports Easy for You
With CER Navigator, handling MDR and MDCG compliant clinical evaluation reports becomes simple. Made just for you, our platform guarantees compliance, enhances your efficiency, and lightens your workload by 80%
- Trusted
- Compliant
- User-centric
- Time-saving
How CER Navigator Helps You at Each Stage of Your Clinical Evaluation Process:
Starting a clinical evaluation, as required by the Medical Device Regulation (MDR) and MDCG guidance, demands precision, compliance, and expertise.
CER Navigator, rooted in regulatory best practices, serves as your strategic ally, ensuring each phase of the clinical evaluation is executed with rigorous adherence to standards. Here’s how CER Navigator supports you and simplifies each stage of your clinical evaluation process:
Stage 0.
Scoping & Plan
Initiate your process with our Clinical Evaluation Plan template, meticulously crafted in compliance with MDR and MDCG guidance and validated by leading notified bodies.
Use the precision of our AI-driven tools to delineate your clinical evaluation scope
Our platform, designed with the expertise of quality engineers and clinical evaluation specialists in mind, offers a user-centric interface, empowering you to navigate the complexities of the regulatory landscape with confidence and efficiency.
Stage 1.
Identification of pertinent data
Instead of sifting through vast amounts of literature manually, our automated AI-powered tools enable you to pinpoint and select pertinent articles, ensuring your state-of-the-art reports are both comprehensive and in strict alignment with MDR stipulations.
Our platform’s direct integration with vigilance databases, notably MAUDE, streamlines your post-market surveillance data retrieval, ensuring you meet the criteria set by Article 83 of the MDR without getting bogged down in extensive Excel datasets.
Additionally, our advanced AI extraction tool is designed to retrieve specific data from selected pertinent data sources, optimizing your workflow and reinforcing adherence to MDCG guidance.
Use our AI tool to generate your selection report effortlessly, be it in PRISMA format or another, with just a button click.
Stage 2.
Appraisal of pertinent data
With CERNavigator, you have access to appraisal scores validated by notified bodies, ensuring your evaluations align seamlessly with MDR and MDCG guidelines. Our platform also allows for the integration of your specific scores.
Utilize our AI-powered appraisal tools to swiftly assess the scientific validity, relevance, and weighting of each dataset, accelerating your appraisal process and saving valuable time.
Use our AI tools to generate comprehensive appraisal reports effortlessly with just a click.
Stage 3.
Analysis of the clinical data
Using CER Navigator’s AI-driven capabilities for an in-depth analysis of clinical data, you can bypass repetitive tasks, minimize errors, enhance the quality of your reports, and significantly expedite the process.
In fact, our tools seamlessly integrate all selected and appraised clinical data, guiding you through the process of crafting your clinical data analysis.
The platform’s user-centric design ensures you’re always at the heart of the CER creation process, with the flexibility to modify any section as needed.
Stage 4.
Finalize the Clinical Evaluation Report (CER)
Efficiently produce CERs that are audit-compliant, adhering strictly to MDR and MDCG regulatory standards, all achievable with a singular click. Implement rigorous change tracking, version management, and foster seamless collaboration throughout the CER development process.
We also provide expert consultancy from our global team of clinical evaluation specialists, accessible with just a click. CERNavigator is designed for interactive engagement, ensuring your active involvement in every step of the CER creation, promoting a synergistic approach
Why Choose CER Navigator
The Gold Standard in CER Management
Opt for CER Navigator, a platform meticulously crafted in alignment with MDR and MDCG standards. Recognizing the paramount importance of precision and efficiency in the clinical evaluation landscape, CER Navigator is tailored to facilitate a robust, compliant, and efficient process. By integrating with our system, you position yourself to not only meet but exceed regulatory expectations, all while optimizing time and minimizing workload in accordance with best industry practices
MDR & MDCG Alignment
Designed in strict accordance with the Medical Device Regulation (MDR) and MDCG guidelines.
Secure Data Management
Your clinical data's security is paramount to us. Stored encrypted on our servers, only you can access it, ensuring utmost confidentiality
Audit-Ready Reports
Generate CERs that are prepared for regulatory scrutiny and audits.
AI-Powered Efficiency
Advanced AI tools streamline the CER process, reducing manual effort and potential for errors.
Reduced Workload
With tools designed for efficiency, experience a significant reduction in manual tasks, lightening your team's workload.
Interactive Platform
A user-centric design that emphasizes collaboration and active involvement in the CER process.
Time-Saving Automation
Automated processes drastically cut down the time required for CER creation and review.
Cost-Effective
Priced per project, ensuring you only pay for what you use, maximizing value.
Regulatory Expertise
Access to a team of clinical evaluation specialists well-versed in MDR and MDCG intricacies.
Testimonials
What Our Clients Say?
F.A.Q.
Dive into our frequently asked questions to get a clearer understanding of CERNavigator. If your query isn't addressed here, please reach out to us directly.
Both, actually! While CERNavigator is a software platform designed to streamline the clinical evaluation process, we also have a team of Regulatory professionals available to assist as needed. The choice is yours.
Not entirely. While we incorporate AI to enhance and streamline the process, our team of experienced Regulatory professionals are at the helm of conducting your clinical evaluation report or assisting you in crafting your own. Our primary goal is efficiency and time-saving
Our pricing model is project-centric, not user-centric. This means you pay only for the projects you undertake. We maintain transparency with a flat fee per project and an optional annual fee for data storage.
Certainly! We offer custom demos and trial uses for specific companies. Contact us for more details.
CERNavigator is designed to automate the entire clinical evaluation process. Our platform is more streamlined than traditional SLR tools, enabling users to initiate, search, and review within minutes, eliminating the need for extensive training or setup
Absolutely! Our platform can automate searches of the FDA Maude database and provides a structured approach to organize and conduct searches across major global adverse event databases
Flexibility is key. We offer multiple output formats, from a comprehensive Excel export (inclusive of review information and citations) to a polished Microsoft Word document that’s ready for submission. We also support Endnote outputs.
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