Do you require a performance evaluation or performance study for your IVD? Would you like to apply and further develop your medical device under controlled conditions? We support your access to the European market.
LX CRO Services
Performance Evaluations
Do you require a performance evaluation or performance study for your IVD? Would you like to apply and further develop your medical device under controlled conditions?
We support your access to the European market.
Performance Studies & Evaluations
Reliable support from development through post-market activities
Regardless of your IVD’s risk class, our experienced multidisciplinary team of scientists, engineers and physicians will assess your specific situation. If you are preparing your IVD for CE marking, we identify the data required for your device, its intended use and its clinical performance in line with the intended purpose. Or do you require a post-market performance evaluation for an IVD that has already been successfully placed on the market?
In that case, we proactively collect and analyse the relevant data and prepare a report demonstrating the clinical performance and safety of your IVD. In accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), you can draw on our expertise in scientific validity, analytical performance, clinical performance as well as safety.
Our services related to your IVD product take into account the requirements of Articles 56–77 of the IVDR and the ISO 20916 standard.
Services Included
In Vitro Diagnostic Medical Devices (IVDs)
What type of performance study does my product require—or is a clinical performance study required at all? Which stage of the clinical lifecycle has my product reached? How much clinical data needs to be generated?
This section helps you answer these and other key questions.
Full-Service CRO
Your Advantage with LX CRO
Benefit from the combined expertise of our multidisciplinary medical writing team. As a full-service CRO specializing in medical devices and IVDs, we support both individual work packages as well as international, multicenter studies—from project management and design of the study through to the final Clinical Investigation Report.
Tailored Service Options
Let’s discuss your requirements and determine which option is right for you: One of our flexible modular services? Or one of our service packages? The choice is yours.
Transparent Cost Structure
Whether you choose modular services or our comprehensive end-to-end package, you will receive a detailed proposal with a clear and fully transparent cost breakdown.
Your ROI—Predictable and Secure
Our expertise helps you achieve your objectives faster, more efficiently and with greater cost control. We turn complex requirements into clear processes and targeted actions. This makes the return on your investment manageable.
IVD Enquiry
Dedicated expertise for your IVD study
Have you developed an innovative in vitro diagnostic medical device and are now preparing to bring it to market? We support you across the key processes!
We ensure that all interfaces and responsibilities are clearly defined and properly managed. With us, your projects stays aligned with current clinical and regulatory requirements.
Service Packages
Everything you need—from planning to regulatory approval
Rather than offering isolated services, our tailored packages provide an integrated solution from planning through to regulatory approval. Structured project management, clearly defined processes and evidence-based decision-making ensure efficiency, quality and regulatory compliance at every stage.