Our IVDR expertises

Your Research, Our Expertise: Unmatched Study Design, Monitoring, and Reporting Services

From concept to conclusion, Cerba Xpert offers a comprehensive suite of services to ensure the success of your research. Our team of experts provides unparalleled guidance in study design, rigorous monitoring, and detailed reporting for each IVDR step.

Ensuring Scientific Validity for Reliable Diagnostics

At Cerba Xpert, we recognize the importance of scientific validity in the development and validation of in vitro diagnostic (IVD) medical devices. Our commitment to rigorous standards guarantees accurate, reliable, and clinically relevant tests.

Comprehensive Scientific Validity Reports

Cerba Xpert provides comprehensive scientific validity reports that covers analytical validity, clinical performance, and scientific validity to support regulatory submissions. Our expertise in navigating complex regulatory requirements, including the IVDR, ensures compliance with global standard, facilitating smooth market entry for your product

Tailored Solutions for Medical Devices and Diagnostics

We offer tailored scientific validity solutions to meet the unique needs of each client, whether you are developing innovative diagnostics or enhancing existing IVD medical devices. Our services include scientific literature review, performance studies, and regulatory documentation to meet your specific needs. We collaborate closely with you to understand your challenges and objectives, providing customized strategies for successful regulatory approval and market acceptance.

Why Choose Cerba Xpert for Scientific Validity?

• Proven Expertise: Strong experience in clinical research and regulatory affairs.
• Global Reach: Extensive knowledge of European regulatory requirements and market dynamics.
• Innovative Approaches: Utilizing the latest technologies and methodologies to ensure precise and reliable results.
• Client-Centric: Focused on delivering exceptional service and tailored support to your needs.

Contact us today to learn how Cerba Xpert can support the scientific validity of your IVD medical devices.

Elevate Your IVD Device with Superior Analytical Performance by Cerba Xpert

Analytical performance is pivotal for the validation and regulatory approval of in vitro diagnostic (IVD) devices. As defined under the European Regulation IVDR 2017/746, analytical performance is the ability of a device to accurately detect or measure a specific analyte. This encompasses ensuring reliable, accurate, and consistent results across various specimen types and under diverse conditions​.

Core Parameters in Analytical Performance Studies

To ensure the highest quality, safety, and efficacy of IVD devices, our comprehensive analytical performance studies evaluate key parameters such as sensitivity, specificity, trueness, precision, limits of detection and quantitation, measuring range and linearity, interfering substance, cross-reactivity, cut-off values, stability, etc.​​

Comprehensive Support by Cerba Xpert

Cerba Xpert offers a full suite of services to support manufacturers in their analytical performance studies, ensuring compliance with international standards like CLSI guidelines. Our services include writing the study plan, biospecimen provision, testing, data analysis, and compliance.

Why Partner with Cerba Xpert for analytical performance?

• Cerba Xpert distinguishes itself as a reliable partner through:
• Strict adherence to international guidelines
• Efficient and cost-effective execution of performance studies
• Comprehensive documentation and data integrity​

Contact us today to learn more about how we can support your IVD device's analytical performance.

Drive Success with Our Advanced Clinical Performance Solutions

At Cerba Xpert, we understand the critical role of clinical performance in ensuring the safety, efficacy, and regulatory compliance of in vitro diagnostic (IVD) medical devices. Our comprehensive Clinical Performance Evaluation services offer a comprehensive approach to guide you through every stage of the process, from initial testing to regulatory submission.

What does Cerba Xpert Offer?

Expert Guidance and Consultation:  Our seasoned experts provide tailored advice on study design, protocol development, and regulatory requirements to ensure your product meets all necessary benchmarks

End-to-End Study Management: From study initiation to completion, we handle all aspects of your clinical performance evaluation, including:

• Protocol Plan development
• Site selection and management
• Data monitoring
• Analysis and reporting

Regulatory Compliance:  Our team ensures your clinical performance evaluation meets the stringent requirements of major regulatory bodies, such as the IVD Regulation 2017/746.

Customized Solutions:  Recognizing that each IVD medical device is unique, we offer tailored solutions to address your specific needs, whether you are developing a new device or enhancing an existing one.

Why Choose Cerba Xpert?

Proven Expertise:  Our team brings unparalleled experience in clinical performance evaluations, with a proven track record of successful submissions and approvals

Cutting-Edge Facilities: Our state-of-the-art laboratories and facilities, including different IVD techniques for your predicate, ensure accurate and reliable results

Access to samples: Thanks to the Cerba Heathcare lab network we have access to a wide range of patient samples with all ethical documentation needed.

Global Reach: Our international network allows us to conduct studies in multiple regions, providing access to diverse patient populations

Ready to discuss your clinical performance evaluation needs? Contact Cerba Xpert today to learn more about how we can support your project and ensure your product’s success.

Mastering Usability: Elevate Your Medical Devices with Expert Testing

Ensuring that in vitro diagnostic (IVD) medical devices are user-friendly is essential for patient safety and effectiveness. At Cerba Xpert, our usability studies are designed to evaluate and enhance the interaction between users and medical devices.

Key Services:

• User Interface Evaluation: the ease of use and accessibility of your device's interface.
• Error Analysis: We conduct structured testing with real users to gather feedback.
• Regulatory Alignment: We ensure that your device meets all relevant usability standards.

How We Work:

• Initial Review: We analyze existing design documents and user profiles.
• Testing Phases: Conduct structured testing with real users to gather feedback and measure performance.
• Detailed Reporting: We provide a comprehensive report with recommendations for improvement.

Benefits of Our Usability Studies:

• Enhanced Safety: Minimize the risk of user errors and improve overall device safety.
• Regulatory Compliance: Ensure your device meets regulatory requirements.
• Improved User Satisfaction: Enhance user satisfaction and device effectiveness.

Learn how Cerba Xpert can improve your IVD device's usability. Contact us today.

Cerba Xpert offers comprehensive post-market surveillance (PMS) solutions for in vitro diagnostic (IVD) medical devices. These services ensure ongoing compliance with regulations, enhance patient safety, and support product lifecycle management.

Why Post-Market Surveillance Matters

PMS is crucial for identifying and addressing any potential issues that arise after your product has been released to the market. It helps ensure ongoing compliance with regulatory requirements and enhances patient safety by detecting and mitigating risks that may not have been apparent during pre-market testing.

Our Post-Market Surveillance Offerings

• Regulatory Compliance: We help you maintain compliance with IVDR regulations through rigorous monitoring, reporting, and ensuring adherence to the latest standards and guidelines
• Performance Monitoring: We offer continuous evaluation of device performance in real-world settings, analyzing data such as clinical data, user feedback, and adverse event reports
• Risk Management: We provide comprehensive risk management services, including assessment, mitigation, and developing effective strategies to address emerging issues
• Data Collection and Analysis Using advanced tools and methodologies, they collect and analyze data to provide accurate insights and support evidence-based decision-making
• Regulatory Reporting: We assist with preparing and submitting required reports to regulatory authorities, ensuring accuracy and timeliness
• Customer Support and Feedback Integration: We facilitate communication with end-users to gather feedback and enhance product quality

Why Choose Cerba Xpert?

• Expertise: Our team of regulatory and clinical experts has extensive experience in PMS and a deep understanding of IVDR regulations
• Innovation: We utilize state-of-the-art technologies and methodologies
• Proactive Approach: Our proactive approach helps identify potential issues early to ensure product safety and efficacy

Ensure the ongoing safety and compliance of your IVD medical devices with Cerba Xpert's expert post-market surveillance services, contact us today.

Achieve Regulatory Excellence: Cerba Xpert, Your Partner in IVDMD Compliance

Navigating the complex regulatory landscape of In Vitro Diagnostic Medical Devices (IVDMD) can be challenging. At Cerba Xpert, we specialize in providing comprehensive regulatory support to ensure that your products meet the stringent requirements set by international health authorities. Our expert team is dedicated to guiding you through every step of the regulatory process to achieve compliance and facilitate successful market entry.

Our Expertise

• IVDR Compliance: We offer in-depth support for the In Vitro Diagnostic Regulation (IVDR 2017/746) compliance, ensuring your products adhere to the latest European standards.
• Clinical Evaluation and Performance Studies: We support the design and execution of clinical evaluations and analytical performance studies necessary for regulatory submissions.

Why Choose Cerba Xpert?

• Experienced Professionals: Our regulatory affairs experts have extensive experience in the medical device and diagnostics industry.
• Customized Solutions: We understand that every product and market is unique. Our approach is tailored to meet your specific needs.
• Comprehensive Support: From initial regulatory strategy development to post-market surveillance, Cerba Xpert offers end-to-end regulatory support.

Ready to navigate the complexities of regulatory compliance with confidence? Contact Cerba Xpert today. Our team is here to provide you with the expertise and support you need for successful regulatory outcomes.