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%

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.


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.


What Our Clients Say?

CER Navigator offers the perfect blend of autonomy and guidance. Using the platform on my own, I felt fully equipped to navigate the intricacies of CERs, yet reassured knowing expert assistance was just a click away. It's the ideal tool for professionals who value independence without compromising on quality
Dr. Amelia Richardson
Clinical Evaluation Specialist
Working with CER Navigator felt like an honest partnership. They took the burden of lengthy, meticulous CERs off my shoulders, saving me potentially months of work. Their approach was both hands-off and hands-on, ensuring I was always part of the decision-making process. The efficiency and professionalism surpassed all my expectations.
Jane Doe,
Clinical Evaluation Expert
Engaging with CER Navigator was a game-changer. Their expertise lightened the heavy load of CERs, granting me valuable time back. Their balanced approach kept me central to decisions, and their efficiency and professionalism were unmatched. Truly a standout experience.
John Smith
RAQA Engineer
The platform's integration with vigilance databases and its automated data extraction are unmatched. CERNavigator has become an indispensable tool for our medical device company
Emily Brown
Clinical Evaluation Specialist
CER Navigator transformed our clinical evaluation process. Its intuitive design and expert-driven features made compliance and report generation a breeze. A game-changer for our regulatory team!
Ms. Clara Bennett
Senior Medical Writer
Navigating the complexities of CERs has never been easier. With CERNavigator, I felt empowered and informed every step of the way. Their expertise and user-friendly platform are truly unmatched in the industry
Catherine Gilbert
Senior Medical Writer


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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