Assay Development Services
Our comprehensive Research, Design, and Development services are designed to bring your product to market efficiently. Combine your innovative idea with our expertise to successfully launch your product.
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Small Scale Manufacturing
We specialize in manufacturing ELISA and Turbidimetric Assays. From small-scale to larger productions, we cater to all project sizes—no project is too small.
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Our Services
We offer specialized services for IVD products, designed to ensure your diagnostics meet the highest standards of accuracy and reliability. Entrust us to enhance the effectiveness of your IVD solutions, ensuring they deliver consistent and precise results in every use.
The exceptional quality of our services is guaranteed by our ISO 13485 certification, proudly held since 2020. This ensures that you receive only the highest standard of service, consistently delivered to meet stringent global requirements.
Our expertise in IVDR and FDA regulations ensures compliance with international requirements.
The production and development services apply to IVD products which are based on the following analytical methods:
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Turbidimetric assay
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ELISA assay
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Lateral Flow Immunoassay
Analytical Performance Evaluation
Ensure precision and accuracy in your IVD products. We assess reliability, sensitivity, and specificity under various conditions to meet industry standards and regulatory requirements. Our thorough analysis of test repeatability and reproducibility guarantees consistency and reliability in clinical settings.
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Verification and Validation
We ensure top-quality and compliance for medical devices and IVD products. Our verification process confirms that product outcomes meet all initial requirements, thoroughly checking and validating every design aspect. Through validation, we provide evidence that your product meets necessary requirements for its intended use, ensuring reliable performance in real-world scenarios and adherence to all regulations.
Manufacturing of IVD products
Specializing in turbidimetric and ELISA-based products, we adhere to ISO 13485 standards, ensuring top-quality production and documentation through rigorous quality control.
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Samples Measurements – vary biomarkers for studies
We provide specialized sample measurement services using ELISA readers and Roche Cobas analyzers for a diverse range of tests.
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Failure investigation of assays
We offer consulting services to resolve issues with ELISA, LFI, and turbidimetric assays, assisting in product development, manufacturing, and post-market processes.
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Development of LFI reading methods- consulting
We specialize in advanced Lateral Flow Immunoassay (LFI) reading methods, offering development and consultancy services to enhance assay performance and streamline operations.
Failure investigation of assays
We offer consulting services to resolve issues with ELISA, LFI, and turbidimetric assays, assisting in product development, manufacturing, and post-market processes.
Industries
MedTech - Startups
Starting a new MedTech venture can be challenging. We provide essential guidance to help startups minimize trial and error. Our team assists in conducting initial studies to ensure biomarkers perform as expected, giving you a strong foundation to build on.
MedTech - SME's
Running a successful SME and need additional support in the lab or with regulatory affairs? We’re here to help. Whether you require a reference lab for market surveillance or a second laboratory for performance evaluation studies, our expertise is at your service.
Hospitals and Pharma
Need laboratory tests for any biomarker? We offer comprehensive testing services to meet your requirements.
Case Study
Our Decade-Long Partnership with ViroGates A/S
Since 2014, ViroGates A/S and NUTOPI Sp. z o.o. have built a robust partnership that underscores our commitment to excellence and innovation in the MedTech industry.
Initially, ViroGates outsourced their laboratory work to NUTOPI, entrusting us with measuring biological materials for studies that were later published in prestigious scientific journals.
ViroGates has published more than 1000 articles as of 2024, significantly advancing the understanding and application of suPAR.
“Our partnership with NUTOPI Sp. z o.o. has been instrumental in advancing our mission to spread knowledge about suPAR and bring innovative diagnostic solutions to market. Since 2014, NUTOPI has consistently demonstrated their expertise and commitment to excellence, contributing to scientific articles and managing our production with the highest quality standards.
Their role in developing products for additional platforms for suPAR and their unwavering support have made them an invaluable partner in our journey.
I highly recommend NUTOPI to any MedTech company looking for a reliable and innovative cooperation partner.”
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Jakob Knudsen
Our Partners and Clients
